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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97816

116 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 29, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
B Braun Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

116 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 116

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1484.

Z-0603-2026
Recall number
Z-0603-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
43,900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: V1443; Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447; Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448; Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. 4. Catalog Number: V1484; Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 2 of 116

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER; Catalog Number: 352447.

Z-0604-2026
Recall number
Z-0604-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352447; Primary UDI-DI: 04046964181665; Unit of Use UDI-DI: 04046964181658.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 3 of 116

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.

Z-0605-2026
Recall number
Z-0605-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
12,700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352062; Primary UDI-DI: 04046964181160; Unit of Use UDI-DI: 04046964181153.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 4 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.

Z-0606-2026
Recall number
Z-0606-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
32,436 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490189; Primary UDI-DI: 04046964303586; Unit of Use UDI-DI: 04046964303579. 2. Catalog Number: 490226; Primary UDI-DI: 04046964304262; Unit of Use UDI-DI: 04046964304255.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 5 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.

Z-0607-2026
Recall number
Z-0607-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
104,784 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490469; Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. 2. Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 6 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT SET; Catalog Number: 490467.

Z-0608-2026
Recall number
Z-0608-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
14,712 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490467; Primary UDI-DI: 04046964958779; Unit of Dose UDI-DI: 04046964958762.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 7 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 134 IN.; Catalog Number: 490477.

Z-0609-2026
Recall number
Z-0609-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
36,552 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490477; Primary UDI-DI: 04046964991271; Unit of Dose UDI-DI: 04046964991264.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 8 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D, 144 IN.; Catalog Number: 490472.

Z-0610-2026
Recall number
Z-0610-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
10,536 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490472; Primary UDI-DI: 04046964958878; Unit of Dose UDI-DI: 04046964958861.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 9 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DROPS/ML 125 IN; Catalog Number: 490452.

Z-0611-2026
Recall number
Z-0611-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
19,392 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490452; Primary UDI-DI: 04046964848933; Unit of Dose UDI-DI: 04046964848926.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 10 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D 2 CARESITE LAD, 126 IN; Catalog Number: 490444.

Z-0612-2026
Recall number
Z-0612-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
88,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490444; Primary UDI-DI: 04046964848773; Unit of Dose UDI-DI:04046964848766.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 11 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2-HIGH FLOW STPCKS, 124 IN; Catalog Number: 490476.

Z-0613-2026
Recall number
Z-0613-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
19,320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490476; Primary UDI-DI: 04046964958953; Unit of Dose UDI-DI:04046964958946.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 12 of 116

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 117 IN.; Catalog Number: 490468.

Z-0614-2026
Recall number
Z-0614-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
58,752 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490468; Primary UDI-DI: 04046964958793; Unit of Dose UDI-DI: 04046964958786.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 13 of 116

B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 60 DROPS/ML,141 in.; Catalog Number: 490349.

Z-0615-2026
Recall number
Z-0615-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
24,648 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490349; Primary UDI-DI: 04046964602405; Unit of Dose UDI-DI: 04046964602399.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 14 of 116

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET 124 IN.; Catalog Number: 490196.

Z-0616-2026
Recall number
Z-0616-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
7,344 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490196; Primary UDI-DI: 04046964303722; Unit of Dose UDI-DI: 04046964303715.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 15 of 116

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170 ?M FILTER 120 IN; Catalog Number: 490355.

Z-0617-2026
Recall number
Z-0617-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
24,624 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490355; Primary UDI-DI: 04046964616013; Unit of Dose UDI-DI: 04046964616006.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 16 of 116

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, 3 CARSITE LADS, 146 IN; Catalog Number: 490530.

Z-0618-2026
Recall number
Z-0618-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
33,528 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490530; Primary UDI-DI: 04046955203321; Unit of Dose UDI-DI: 04046955203314.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 17 of 116

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, HAND PUMP, 146 IN.; Catalog Number: 490438.

Z-0619-2026
Recall number
Z-0619-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
164,568 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490438; Primary UDI-DI: 04046964833441; Unit of Dose UDI-DI: 04046964833434.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 18 of 116

Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170¿M FILTER; Catalog Number: 480233.

Z-0620-2026
Recall number
Z-0620-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
5,448 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 480233; Primary UDI-DI: 04046955083572; Unit of Dose UDI-DI: 04046955083565.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 19 of 116

Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. BURETTE SET, 4 CARESITE LADS, STPCK 125"; Catalog Number: 490252.

Z-0621-2026
Recall number
Z-0621-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
12,320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490252; Primary UDI-DI: 04046955545636; Unit of Dose UDI-DI: 04046955545629.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 20 of 116

Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. BURETTE SET W/ 2 CARESITE, 134 IN.; Catalog Number: 490159.

Z-0622-2026
Recall number
Z-0622-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
7,240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

Catalog Number: 490159; Primary UDI-DI: 04046964303128; Unit of Dose UDI-DI: 04046964303111.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 21 of 116

CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310.

Z-0623-2026
Recall number
Z-0623-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
4,438 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354302; Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939. 2. Catalog Number: 354303; Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417. 3. Catalog Number: 354304; Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953. 4. Catalog Number: 354305; Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431. 5. Catalog Number: 354306; Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977. 6. Catalog Number: 354307; Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455. 7. Catalog Number: 354308; Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991. 8. Catalog Number: 354310; Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 22 of 116

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

Z-0624-2026
Recall number
Z-0624-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
12,225,913 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354204; Primary UDI-DI: 04046964182075; Unit of Dose UDI-DI: 04046964182068. 2. Catalog Number: 354205; Primary UDI-DI: 04046964182099; Unit of Dose UDI-DI: 04046964182082. 3. Catalog Number: 354206; Primary UDI-DI: 04046964182112; Unit of Dose UDI-DI: 04046964182105.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 23 of 116

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/2 CARESITE; Catalog Number: 354202. 2. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADM 15DROP W/2 CARESITE SLIDECLMP; Catalog Number: 354203.

Z-0625-2026
Recall number
Z-0625-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
2,871,707 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354202; Primary UDI-DI: 04046964182037; Unit of Dose UDI-DI: 04046964182020. 2. Catalog Number: 354203; Primary UDI-DI: 04046964182051; Unit of Dose UDI-DI: 04046964182044.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 24 of 116

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207.

Z-0626-2026
Recall number
Z-0626-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
381,850 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354207; Primary UDI-DI: 04046964182136; Unit of Dose UDI-DI: 04046964182129.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 25 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AS152V2DLL; Catalog Number: 473309.

Z-0627-2026
Recall number
Z-0627-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
11,650 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 473309; Primary UDI-DI: 04046964299636; Unit of Dose UDI-DI: 04046964299629.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 26 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ET08US EXTENSION SET W/ULTRA Y SITE; Catalog Number: 474912.

Z-0628-2026
Recall number
Z-0628-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
30,250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 474912; Primary UDI-DI: 04046964300615; Unit of Dose UDI-DI: 04046964300608.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 27 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD; Catalog Number: 456520.

Z-0629-2026
Recall number
Z-0629-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
2,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 456520; Primary UDI-DI: 04046964296697; Unit of Dose UDI-DI: 04046964296680.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 28 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. EXTENSION SET, 18 IN; Catalog Number: 490448. 2. EXTENSION SET, 52 IN.; Catalog Number: 490465. 3. EXTENSION SET 49 IN.; Catalog Number: 490486. 4. EXTENSION SET, 12 CARESTITE LADS; Catalog Number: 490577.

Z-0630-2026
Recall number
Z-0630-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
43,452 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490448; Primary UDI-DI: 04046964848858; Unit of Dose UDI-DI: 04046964848841. Shelf Life: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490465; Primary UDI-DI: 04046964950735; Unit of Dose UDI-DI: 04046964950728. Shelf Life: Earliest Exp of Comp or 36mths. 3. Catalog Number: 490486; Primary UDI-DI: 04046964991257; Unit of Dose UDI-DI: 04046964991240. Shelf Life: Earliest Exp of Comp or 24mths. 4. Catalog Number: 490577; Primary UDI-DI: 04046955287536; Unit of Dose UDI-DI: 04046955287529. Shelf Life: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 29 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET, 25 IN.; Catalog Number: 490629.

Z-0631-2026
Recall number
Z-0631-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
13,128 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490629; Primary UDI-DI: 04046955665051; Unit of Dose UDI-DI: 04046955665044.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 30 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET W/ B/C VLV, ULTRAPORT, 57 IN.; Catalog Number: 490202.

Z-0632-2026
Recall number
Z-0632-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
13,600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490202; Primary UDI-DI: 04046964303845; Unit of Dose UDI-DI: 04046964303838.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 31 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ B/C VALVE 53 in.; Catalog Number: 490358.

Z-0633-2026
Recall number
Z-0633-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490358; Primary UDI-DI: 04046964642746; Unit of Dose UDI-DI: 04046964642739.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 32 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ ULTRAPORT, 48 IN.; Catalog Number: 490291.

Z-0634-2026
Recall number
Z-0634-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
23,650 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490291; Primary UDI-DI: 04046964716768; Unit of Dose UDI-DI: 04046964716751.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 33 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET ULTRAPORT STOPCOCK, 37IN.; Catalog Number: 490234.

Z-0635-2026
Recall number
Z-0635-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
27,480 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490234; Primary UDI-DI: 04046964716362; Unit of Dose UDI-DI: 04046964716355.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 34 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET W/ 6 B/C VALVES, 17 IN; Catalog Number: 490238.

Z-0636-2026
Recall number
Z-0636-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
11,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490238; Primary UDI-DI: 04046964716409; Unit of Dose UDI-DI: 04046964716393.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 35 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOLD; Catalog Number: 456521. 2. ANES SET W/TRIPLE LL SAFEPORT MANIFOLD; Catalog Number: 456522.

Z-0637-2026
Recall number
Z-0637-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
61,423 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 456521; Primary UDI-DI: 04046964296710; Unit of Dose UDI-DI: 04046964296703. 2. Catalog Number: 456522; Primary UDI-DI: 04046964296734; Unit of Dose UDI-DI: 04046964296727.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 36 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Caresite Extension Set_Export; Catalog Number: 470183.

Z-0638-2026
Recall number
Z-0638-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
32,500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 470183; Primary UDI-DI: 04046964719400; Unit of Dose UDI-DI: 04046964715549.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 37 of 116

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT/2INJ/FLBL/FML LRLK/CV 34; Catalog Number: V5405.

Z-0639-2026
Recall number
Z-0639-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
300 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: V5405; Primary UDI-DI: 04046964188978; Unit of Dose UDI-DI: 04046964188961.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 38 of 116

Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032. 2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033. 3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034. 4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿; Catalog Number: 362043. 5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050. 6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420. 7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE; Catalog Number: 362431. 8. SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; Catalog Number: 362432. 9. 60 DROP METRISET PUMP SET,3 SFLINE ASV; Priming volume: 21mL, length: 121in, SafeLine; Catalog Number: 363010. 10. Y-TYPE BLOOD PUMP SET, SAFELINE, ASV; Priming volume: 40mL, length: 123in, SafeLine; Catalog Number: 363019. 11. UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 363030. 12. UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV; 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; Catalog Number: 363230. 13. Y-TYPE BLOOD PUMP SET, CARESITE, ASV; Priming volume: 41mL, length: 120in, CARESITE; Catalog Number: 363419. 14. SPACE PUMP IV SET, 2 CARESITES, ASV; 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; Catalog Number: 363420. 15. UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 363421. 16. 60DROP METRISET PUMP, 3 CARESITES, ASV; Priming volume: 21mL, length: 130in, CARESITE; Catalog Number: 363422. 17. UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV; 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; Catalog Number: 363423. 18. UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; Catalog Number: 363424. 19. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; Catalog Number: 363430. 20. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; Catalog Number: 363433. 21. SPACE PUMP IV SET 15D, 110 IN.; "SPACE PUMP IV SET 15D, 110 IN. CLOSE"; Catalog Number: 480254. 22. SPACE PUMP IV SET, 127 IN.; SPACE PUMP IV SET, 127 IN.; Catalog Number: 480255. 23. SPACE PUMP SET 15D, CARESITE LAD 122 IN. ; 15 drops/mL, priming volume: 23mL, length: 122in, CARESITE; Catalog Number: 480256. 24. 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; Catalog Number: 480258. 25. SPACE PUMP IV SET 15D, 90 IN.; SPACE PUMP IV SET 15D, 90 IN.; Catalog Number: 480263. 26. UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 490100. 27. 60 DROP METRISET PUMP SET, 3 CARESITES; Priming volume: 19mL, length: 120in, CARESITE; Catalog Number: 490101.

Z-0640-2026
Recall number
Z-0640-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
49,330,370

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 362032; Primary UDI-DI: 04046964182556; Unit of Dose UDI-DI: 04046964182549. Shelf Life: Earliest Exp of Comp or 60mths. 2. Catalog Number: 362033; Primary UDI-DI: 04046964837821; Unit of Dose UDI-DI: 04046964837814. Shelf Life: Earliest Exp of Comp or 36mths. 3. Catalog Number: 362034; Primary UDI-DI: 04046964182570; Unit of Dose UDI-DI: 04046964182563. Shelf Life: Earliest Exp of Comp or 48mths. 4. Catalog Number: 362043; Primary UDI-DI: 04046964182631; Unit of Dose UDI-DI: 04046964182624. Shelf Life: Earliest Exp of Comp or 60mths. 5. Catalog Number: 362050; Primary UDI-DI: 04046964182655; Unit of Dose UDI-DI: 04046964182648. Shelf Life: Earliest Exp of Comp or 60mths. 6. Catalog Number: 362420; Primary UDI-DI: 04046955592715; Unit of Dose UDI-DI: 04046955592708. Shelf Life: 36mths from Start Date. 7. Catalog Number: 362431; Primary UDI-DI: 04046964294013; Unit of Dose UDI-DI: 04046964294006. Shelf Life: Earliest Exp of Comp or 60mths. 8. Catalog Number: 362432; Primary UDI-DI: 04046964182679; Unit of Dose UDI-DI: 04046964182662. Shelf Life: Earliest Exp of Comp or 60mths. 9. Catalog Number: 363010; Primary UDI-DI: 04046964294174; Unit of Dose UDI-DI: 04046964294167. Shelf Life: Earliest Exp of Comp or 48mths. 10. Catalog Number: 363019; Primary UDI-DI: 04046964294198; Unit of Dose UDI-DI: 04046964294181. Shelf Life: Earliest Exp of Comp or 60mths. 11. Catalog Number: 363030; Primary UDI-DI: 04046964294259; Unit of Dose UDI-DI: 04046964294242. Shelf Life: Earliest Exp of Comp or 60mths. 12. Catalog Number: 363230; Primary UDI-DI: 04046964294495; Unit of Dose UDI-DI: 04046964294488. Shelf Life: Earliest Exp of Comp or 60mths. 13. Catalog Number: 363419; Primary UDI-DI: 04046964294570; Unit of Dose UDI-DI: 04046964294563. Shelf Life: Earliest Exp of Comp or 36mths. 14. Catalog Number: 363420; Primary UDI-DI: 04046964294594; Unit of Dose UDI-DI: 04046964294587. Shelf Life: Earliest Exp of Comp or 36mths. 15. Catalog Number: 363421; Primary UDI-DI: 04046964294617; Unit of Dose UDI-DI: 04046964294600. Shelf Life: Earliest Exp of Comp or 36mths. 16. Catalog Number: 363422; Primary UDI-DI: 04046964294631; Unit of Dose UDI-DI: 04046964294624. Shelf Life: Earliest Exp of Comp or 36mths. 17. Catalog Number: 363423; Primary UDI-DI: 04046964294655; Unit of Dose UDI-DI: 04046964294648. Shelf Life: Earliest Exp of Comp or 36mths. 18. Catalog Number: 363424; Primary UDI-DI: 04046964837906; Unit of Dose UDI-DI: 04046964837890. Shelf Life: Earliest Exp of Comp or 36mths. 19. Catalog Number: 363430; Primary UDI-DI: 04046964294679; Unit of Dose UDI-DI: 04046964294662. Shelf Life: 36mths from Start Date. 20. Catalog Number: 363433; Primary UDI-DI: 04046964837920; Unit of Dose UDI-DI: 04046964837913. Shelf Life: Earliest Exp of Comp or 36mths. 21. Catalog Number: 480254; Primary UDI-DI: 04046955324798; Unit of Dose UDI-DI: 04046955343904. Shelf Life: Earliest Exp of Comp or 36mths. 22. Catalog Number: 480255; Primary UDI-DI: 04046955324804; Unit of Dose UDI-DI: 04046955585403. Shelf Life: Earliest Exp of Comp or 36mths. 23. Catalog Number: 480256; Primary UDI-DI: 04046955324811; Unit of Dose UDI-DI: 04046955585861. Shelf Life: Earliest Exp of Comp or 36mths. 24. Catalog Number: 480258; Primary UDI-DI: 04046955324835; Unit of Dose UDI-DI: 04046955585885. Shelf Life: Earliest Exp of Comp or 36mths. 25. Catalog Number: 480263; Primary UDI-DI: 04046955693931; Unit of Dose UDI-DI: 04046955693924. Shelf Life: Earliest Exp of Comp or 36mths. 26. Catalog Number: 490100; Primary UDI-DI: 04046964186080; Unit of Dose UDI-DI: 04046964186073. Shelf Life: 36mths from Start Date. 27. Catalog Number: 490101; Primary UDI-DI: 04046964186103; Unit of Dose UDI-DI: 04046964186097. Shelf Life: Earliest Exp of Comp or 36mths. 28. Catalog Number: 490102; Primary UDI-DI: 04046964186127; Unit of Dose UDI-DI: 04046964186110. Shelf Life: Earliest Exp of Comp or 36mths. 29. Catalog Number: 490103; Primary UDI-DI: 04046964302107; Unit of Dose UDI-DI: 04046964302091. Shelf Life: Earliest Exp of Comp or 36mths. 30. Catalog Number: 490104; Primary UDI-DI: 04046964186141; Unit of Dose UDI-DI: 04046964186134. Shelf Life: Earliest Exp of Comp or 36mths. 31. Catalog Number: 490105; Primary UDI-DI: 04046964186165; Unit of Dose UDI-DI: 04046964186158. Shelf Life: Earliest Exp of Comp or 36mths. 32. Catalog Number: 490655; Primary UDI-DI: 04046955836383; Unit of Dose UDI-DI: 04046955836376. Shelf Life: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 39 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 10 DROPS/ML, 134 in.; Catalog Number: 490357.

Z-0641-2026
Recall number
Z-0641-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
98,688 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490357; Primary UDI-DI: 04046964644399; Unit of Dose UDI-DI: 04046964644382.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 40 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.

Z-0642-2026
Recall number
Z-0642-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
168,816 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490385; Primary UDI-DI: 04046964730146; Unit of Dose UDI-DI: 04046964730139. 2. Catalog Number: 490401; Primary UDI-DI: 04046964761416; Unit of Dose UDI-DI: 04046964761409.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 41 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1270A SAFELINE ANESTHESIA IV SET; Anesthesia IV Administration Set with 3 CARESITE Injection Sites and Manifold; Catalog Number: NF1270A.

Z-0643-2026
Recall number
Z-0643-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
13,870 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: NF1270A; Primary UDI-DI: 04046964187124; Unit of Dose UDI-DI: 04046964187117.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 42 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. US1295 ULTRASITE IV ADMIN SET 60DROP; Catalog Number: 352394.

Z-0644-2026
Recall number
Z-0644-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352394; Primary UDI-DI: 4046964293375; Unit of Dose UDI-DI: 04046964293368.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 43 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1 ULRAPORT, 141 IN; Catalog Number: 490067.

Z-0645-2026
Recall number
Z-0645-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
407,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490067; Primary UDI-DI: 04046964186042; Unit of Dose UDI-DI: 04046964186035.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 44 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 1 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457506.

Z-0646-2026
Recall number
Z-0646-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,019 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 457506; Primary UDI-DI: 04046964716126; Unit of Dose UDI-DI: 04046964716119.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 45 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN 15D, 2 B/C VLV, 3 CARESITE LADS; Catalog Number: 490653.

Z-0647-2026
Recall number
Z-0647-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490653; Primary UDI-DI: 04046955836338; Unit of Dose UDI-DI: 04046955836345.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 46 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML 120 IN.; Catalog Number: 490428.

Z-0648-2026
Recall number
Z-0648-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
89,552 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354209; Primary UDI-DI: 04046964182150; Unit of Dose UDI-DI: 04046964182143. 2. Catalog Number: 490392; Primary UDI-DI: 04046964737367; Unit of Dose UDI-DI: 04046964737350. 3. Catalog Number: 490428; Primary UDI-DI: 04046964823541; Unit of Dose UDI-DI: 04046964823534.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 47 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DR / mL W/ EXT SET; Catalog Number: 490208.

Z-0649-2026
Recall number
Z-0649-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
40,008 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490208; Primary UDI-DI: 04046964303968; Unit of Dose UDI-DI: 04046964303951.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 48 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN. EXT SET 9 IN.; Catalog Number: 490317.

Z-0650-2026
Recall number
Z-0650-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
6,650 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490317; Primary UDI-DI: 04046964525742; Unit of Dose UDI-DI:04046964525735.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 49 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 3 CARESITE ULTRA ZERO 2/SWAB SAFE; IV Set With 3 CARESITE Injection Sites, ULTRAPORT Zer0 High-Flow, 4-Way Stopcock, and Dual Port SAFEPORT; Catalog Number: 457515.

Z-0651-2026
Recall number
Z-0651-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
135,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 457515; Primary UDI-DI: 04046964716188; Unit of Dose UDI-DI:04046964716171.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 50 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF STOPCOCK,107 IN.; Catalog Number: 490241. 2. IV ADMIN SET W/15 DROPS/ML, 116 IN.; Catalog Number: 490298. 3. IV ADMIN SET,15 DROP,4 CARESITE, 119 IN.; Catalog Number: 490360.

Z-0652-2026
Recall number
Z-0652-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
66,792 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490241; Primary UDI-DI: 04046964716447; Unit of Dose UDI-DI: 04046964716430. 2. Catalog Number: 490298; Primary UDI-DI: 04046964716829; Unit of Dose UDI-DI: 04046964716812. 3. Catalog Number: 490360; Primary UDI-DI: 04046964642609; Unit of Dose UDI-DI: 04046964642487.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 51 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 81 IN W/ 32 IN EXT SET; Catalog Number: 490329.

Z-0653-2026
Recall number
Z-0653-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
18,984 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490329; Primary UDI-DI: 04046964541100; Unit of Dose UDI-DI: 04046964541094.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 52 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks; Catalog Number: 354210. 2. IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN.; Catalog Number: 490389.

Z-0654-2026
Recall number
Z-0654-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,861,111 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354210; Primary UDI-DI: 04046964182174; Unit of Dose UDI-DI: 04046964182167; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490389; Primary UDI-DI: 04046964730207; Unit of Dose UDI-DI: 04046964730191; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 53 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 2 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457504.

Z-0655-2026
Recall number
Z-0655-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
80,650 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 457504; Primary UDI-DI: 04046964716089; Unit of Dose UDI-DI: 04046964716072.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 54 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML 126 IN; Catalog Number: 490283.

Z-0656-2026
Recall number
Z-0656-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
65,904 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490283; Primary UDI-DI: 04046964716669; Unit of Dose UDI-DI: 04046964716652.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 55 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML 124 IN.; Catalog Number: 490427.

Z-0657-2026
Recall number
Z-0657-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
224,856 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490427; Primary UDI-DI: 04046964823527; Unit of Dose UDI-DI: 04046964823510.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 56 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 3 CARESITE, 124 IN.; Catalog Number: 470005.

Z-0658-2026
Recall number
Z-0658-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
29,900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 470005; Primary UDI-DI: 04046964297199; Unit of Dose UDI-DI: 04046964297182.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 57 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP/ML, 105 IN.; Catalog Number: 490242. 2. IV ADMN SET W/15 DROP,2 CARESITE,142 IN.; Catalog Number: 490311. 3. IV ADMIN SET W/15 DROPS/ML 115 in.; Catalog Number: 490353.

Z-0659-2026
Recall number
Z-0659-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
129,480 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490242; Primary UDI-DI: 04046964716461; Unit of Dose UDI-DI: 04046964716454. 2. Catalog Number: 490311; Primary UDI-DI: 04046964539688; Unit of Dose UDI-DI: 04046964525629. 3. Catalog Number: 490353; Primary UDI-DI: 04046964602368; Unit of Dose UDI-DI: 04046964602351.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 58 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,2 CARESITE, TRIP MANIFOLD; Catalog Number: 490343.

Z-0660-2026
Recall number
Z-0660-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,272 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490343; Primary UDI-DI: 04046964593659; Unit of Dose UDI-DI: 04046964593642.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 59 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 CARESITE, 140 IN; Catalog Number: 490309.

Z-0661-2026
Recall number
Z-0661-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
259,392 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490309; Primary UDI-DI: 04046964527517; Unit of Dose UDI-DI: 04046964527500.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 60 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/60 DR/ML, CARESITE,147 IN.; Catalog Number: 490367.

Z-0662-2026
Recall number
Z-0662-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
6,768 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490367; Primary UDI-DI: 04046964669903; Unit of Dose UDI-DI:04046964669798.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 61 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490400.

Z-0663-2026
Recall number
Z-0663-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
19,104 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490400; Primary UDI-DI: 04046964761393; Unit of Dose UDI-DI: 04046964761386.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 62 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.

Z-0664-2026
Recall number
Z-0664-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
11,832 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490315; Primary UDI-DI: 04046964527173; Unit of Dose UDI-DI: 04046964525612. 2.Catalog Number: 490331; Primary UDI-DI: 04046964541148; Unit of Dose UDI-DI: 04046964541131. 3. Catalog Number: 490376; Primary UDI-DI: 04046964718182; Unit of Dose UDI-DI: 04046964718175.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 63 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN W/EXT SET 9 IN.; Catalog Number: 490489.

Z-0665-2026
Recall number
Z-0665-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
3,120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490489; Primary UDI-DI: 04046955086894; Unit of Dose UDI-DI: 04046955086887.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 64 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 125 IN.; Catalog Number: 490487.

Z-0666-2026
Recall number
Z-0666-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
23,160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490487; Primary UDI-DI: 04046955086856; Unit of Dose UDI-DI: 04046955086849.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 65 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS, 162 IN.; Catalog Number: 490484.

Z-0667-2026
Recall number
Z-0667-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
37,656 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490484; Primary UDI-DI: 04046964991219; Unit of Dose UDI-DI: 04046964991202.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 66 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN.; Catalog Number: 490504.

Z-0668-2026
Recall number
Z-0668-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
36,936 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490504; Primary UDI-DI: 04046955135738; Unit of Dose UDI-DI: 04046955135721.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 67 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

Z-0669-2026
Recall number
Z-0669-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
190,625 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490528; Primary UDI-DI: 04046955203284; Unit of Dose UDI-DI: 04046955203277; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490550; Primary UDI-DI: 04046955270347; Unit of Dose UDI-DI: 04046955270330; Expiration Date: Earliest Exp of Comp or 24mths. 3. Catalog Number: 490605; Primary UDI-DI: 04046955352876; Unit of Dose UDI-DI: 04046955352869; Expiration Date: Earliest Exp of Comp or 36mths. 4. Catalog Number: 490616; Primary UDI-DI: 04046955664696; Unit of Dose UDI-DI: 04046955664689; Expiration Date: Earliest Exp of Comp or 36mths. 5. Catalog Number: 490654; Primary UDI-DI: 04046955836369; Unit of Dose UDI-DI: 04046955836352; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 68 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636. 2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. 3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. 4. IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. 5. IV ADMIN SET, 105 IN.; Catalog Number: 477003. 6. IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. 7. IV ADMIN SET, 121 IN.; Catalog Number: 477008. 8. IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. 9. IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. 10. IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. 11. IV ADMIN SET 114 IN.; Catalog Number: 477022. 12. IV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. 13. IV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. 14. IV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. 15. IV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. 16. IV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. 17. IV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. 18. IV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. 19. IV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. 20. IV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. 21. IV ADMIN SET, 125 IN.; Catalog Number: 490547. 22. IV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. 23. IV ADMIN SET, 120IN.; Catalog Number: 490553. 24. IV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. 25. IV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. 26. IV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. 27. IV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. 28. IV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. 29. IV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. 30. IV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. 31. IV ADMIN SET, 111 IN.; Catalog Number: 490563. 32. IV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. 33. IV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. 34. IV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. 35. IV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. 36. IV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. 37. IV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. 38. IV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. 39. IV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. 40. IV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. 41. IV ADMIN SET, 132 IN.; Catalog Number: 490589. 42. IV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. 43. IV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. 44. IV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608. 45. IV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615. 46. IV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618. 47. IV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619. 48. IV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644. 49. IV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657. 50. IV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.

Z-0670-2026
Recall number
Z-0670-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
20,694,734 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date. 2. Catalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date. 3. Catalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date. 4. Catalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date. 5. Catalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths. 6. Catalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths. 7. Catalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths. 8. Catalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths. 9. Catalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths. 10. Catalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths. 11. Catalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths. 12. Catalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths. 13. Catalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths. 14. Catalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths. 15. Catalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths. 16. Catalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths. 17. Catalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths. 18. Catalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths. 19. Catalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths. 20. Catalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths. 21. Catalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths. 22. Catalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths. 23. Catalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths. 24. Catalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths. 25. Catalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths. 26. Catalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths. 27. Catalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths. 28. Catalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths. 29. Catalog Number: 490561; Primary UDI-DI: 04046955275526; Unit of Dose UDI-DI: 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths. 30. Catalog Number: 490562; Primary UDI-DI: 04046955275540; Unit of Dose UDI-DI: 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths. 31. Catalog Number: 490563; Primary UDI-DI: 04046955275564; Unit of Dose UDI-DI: 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths. 32. Catalog Number: 490569; Primary UDI-DI: 04046955275687; Unit of Dose UDI-DI: 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths. 33. Catalog Number: 490573; Primary UDI-DI: 04046955287451; Unit of Dose UDI-DI: 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths. 34. Catalog Number: 490574; Primary UDI-DI: 04046955287475; Unit of Dose UDI-DI: 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths. 35. Catalog Number: 490575; Primary UDI-DI: 04046955287499; Unit of Dose UDI-DI: 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths. 36. Catalog Number: 490578; Primary UDI-DI: 04046955287550; Unit of Dose UDI-DI: 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths. 37. Catalog Number: 490581; Primary UDI-DI: 04046955287611; Unit of Dose UDI-DI: 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths. 38. Catalog Number: 490582; Primary UDI-DI: 04046955287635; Unit of Dose UDI-DI: 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths. 39. Catalog Number: 490583; Primary UDI-DI: 04046955287659; Unit of Dose UDI-DI: 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths. 40. Catalog Number: 490588; Primary UDI-DI: 04046955287758; Unit of Dose UDI-DI: 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths. 41. Catalog Number: 490589; Primary UDI-DI: 04046955287772; Unit of Dose UDI-DI: 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths. 42. Catalog Number: 490600; Primary UDI-DI: 04046955352777; Unit of Dose UDI-DI: 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths. 43. Catalog Number: 490607; Primary UDI-DI: 04046955352913; Unit of Dose UDI-DI: 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths. 44. Catalog Number: 490608; Primary UDI-DI: 04046955352937; Unit of Dose UDI-DI: 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths. 45. Catalog Number: 490615; Primary UDI-DI: 04046955664672; Unit of Dose UDI-DI: 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths. 46. Catalog Number: 490618; Primary UDI-DI: 04046955664733; Unit of Dose UDI-DI: 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths. 47. Catalog Number: 490619; Primary UDI-DI: 04046955664757; Unit of Dose UDI-DI: 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths. 48. Catalog Number: 490644; Primary UDI-DI: 04046955765003; Unit of Dose UDI-DI: 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths. 49. Catalog Number: 490657; Primary UDI-DI: 04046955836420; Unit of Dose UDI-DI: 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths. 50. Catalog Number: 490658; Primary UDI-DI: 04046955836697; Unit of Dose UDI-DI: 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 69 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML, 99 IN; Catalog Number: 490511.

Z-0671-2026
Recall number
Z-0671-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
12,168 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490511; Primary UDI-DI: 04046955135875; Unit of Dose UDI-DI: 04046955135868; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 70 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP, 132 IN; Catalog Number: 490519.

Z-0672-2026
Recall number
Z-0672-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,080 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490519; Primary UDI-DI: 04046955185238; Unit of Dose UDI-DI: 04046955186549; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 71 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESITE LAD, 116 IN; Catalog Number: 490522. 2. IV ADMIN SET 115, IN. W. 9 IN EXT SET; Catalog Number: 490568.

Z-0673-2026
Recall number
Z-0673-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
41,016 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490522; Primary UDI-DI: 04046955203123; Unit of Dose UDI-DI: 04046955203116; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490568; Primary UDI-DI: 04046955275663; Unit of Dose UDI-DI: 04046955275656; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 72 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET WITH 15 DROPS/ML; Catalog Number: 490507.

Z-0674-2026
Recall number
Z-0674-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
48,672 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490507; Primary UDI-DI: 04046955135790; Unit of Dose UDI-DI: 04046955135783; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 73 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expiration Date: Earliest Exp of Comp or 36mths.

Z-0675-2026
Recall number
Z-0675-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
65,232 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 74 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 133 IN.; Catalog Number: 490245.

Z-0676-2026
Recall number
Z-0676-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
40,992 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490245; Primary UDI-DI: 04046964716508; Unit of Dose UDI-DI: 04046964716492; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 75 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 15DR 2SAFELINE 1CARESITE 1STOPCOCK 131IN; Catalog Number: 490612.

Z-0677-2026
Recall number
Z-0677-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
5,952 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490612; Primary UDI-DI: 04046955664610; Unit of Dose UDI-DI: 04046955664603; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 76 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15D, 2 CARESITES, 153 IN.; Catalog Number: 490542.

Z-0678-2026
Recall number
Z-0678-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
7,008 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490542; Primary UDI-DI: 04046955270187; Unit of Dose UDI-DI: 04046955270170; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 77 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.

Z-0679-2026
Recall number
Z-0679-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
15,250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490025; Primary UDI-DI: 04046964301056; Unit of Dose UDI-DI: 04046964301049; Expiration Date: Earliest Exp of Comp or 60mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 78 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062.

Z-0680-2026
Recall number
Z-0680-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
12,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490062; Primary UDI-DI: 04046964301445; Unit of Dose UDI-DI: 04046964301438; Expiration Date: Earliest Exp of Comp or 60mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 79 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 138 IN.; Catalog Number: 490426.

Z-0681-2026
Recall number
Z-0681-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
63,192 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490426; Primary UDI-DI: 04046964823503; Unit of Dose UDI-DI: 04046964823497; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 80 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503.

Z-0682-2026
Recall number
Z-0682-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
187,464 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490488; Primary UDI-DI: 04046955086870; Unit of Dose UDI-DI: 04046955086863; Expiration Date: Earliest Exp of Comp or 24mths. 2. Catalog Number: 490492; Primary UDI-DI: 04046955086757; Unit of Dose UDI-DI: 04046955086740; Expiration Date: Earliest Exp of Comp or 36mths. 3. Catalog Number: 490503; Primary UDI-DI: 04046955135714; Unit of Dose UDI-DI: 04046955135707; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 81 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM 15 DROP W/3 CARESITE N/C DUAL; Catalog Number: 354211.

Z-0683-2026
Recall number
Z-0683-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
286,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354211; Primary UDI-DI: 04046964182198; Unit of Dose UDI-DI: 04046964182181; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 82 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM 15D 2 CARESITE, SAFEPORT MANIFLD; Catalog Number: 354208.

Z-0684-2026
Recall number
Z-0684-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
126,050 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354208; Primary UDI-DI: 04046964293818; Unit of Dose UDI-DI: 04046964293801; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 83 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMN SET W/15 DROP, ULTRAPORT,134 IN.; Catalog Number: 490312. 2. IV ADMIN SET W/ 15 DROPS/ML, 120 IN.; Catalog Number: 490432.

Z-0685-2026
Recall number
Z-0685-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
226,632 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490312; Primary UDI-DI: 04046964525643; Unit of Dose UDI-DI: 04046964525636; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490432; Primary UDI-DI: 04046964832826; Unit of Dose UDI-DI: 04046964832819; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 84 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET, 138 IN.; Catalog Number: 490491.

Z-0686-2026
Recall number
Z-0686-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
960 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490491; Primary UDI-DI: 04046955086931; Unit of Dose UDI-DI: 04046955086924; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 85 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490407.

Z-0687-2026
Recall number
Z-0687-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
10,896 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490407; Primary UDI-DI: 04046964773242; Unit of Dose UDI-DI: 04046964773235; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 86 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ B/C VALVE,103 IN.; Catalog Number: 470179.

Z-0688-2026
Recall number
Z-0688-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
28,344 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 470179; Primary UDI-DI: 04046964773181; Unit of Dose UDI-DI: 04046964773174; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 87 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, QUAD MANIFOLD,120 IN.; Catalog Number: 490340.

Z-0689-2026
Recall number
Z-0689-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
25,728 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490340; Primary UDI-DI: 04046964590481; Unit of Dose UDI-DI: 04046964590474; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 88 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,3 CARESITE LADS, 137 IN; Catalog Number: 490303.

Z-0690-2026
Recall number
Z-0690-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
32,304 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490303; Primary UDI-DI: 04046964526381; Unit of Dose UDI-DI: 04046964526374; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 89 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2 CARESITES, 125 IN.; Catalog Number: 490408.

Z-0691-2026
Recall number
Z-0691-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
24,072 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490408; Primary UDI-DI: 04046964773266; Unit of Dose UDI-DI: 04046964773259; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 90 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 130 IN. IV ADMIN SET W/ 9 IN. EXT SET; Catalog Number: 490412.

Z-0692-2026
Recall number
Z-0692-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
45,288 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490412; Primary UDI-DI: 04046964797989; Unit of Dose UDI-DI: 04046964797972; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 91 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML 115 in.; Catalog Number: 490354.

Z-0693-2026
Recall number
Z-0693-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
41,976 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490354; Primary UDI-DI: 04046964602382; Unit of Dose UDI-DI: 04046964602375; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 92 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 124 IN.; Catalog Number: 490451.

Z-0694-2026
Recall number
Z-0694-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
2,544 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490451; Primary UDI-DI: 04046964848919; Unit of Dose UDI-DI: 04046964848902; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 93 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR HF 4-WAY STPCK 135 IN.; Catalog Number: 490193. 2. IV AD SET, 2 CARESITE, SAFEPORT, 134 IN.; Catalog Number: 490326.

Z-0695-2026
Recall number
Z-0695-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
111,312 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490193; Primary UDI-DI: 04046964303661; Unit of Dose UDI-DI: 04046964303654; Expiration Date: Earliest Exp of Comp or 24mths. 2. Catalog Number: 490326; Primary UDI-DI: 04046964541063; Unit of Dose UDI-DI: 04046964541056; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 94 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML, 118 IN.; Catalog Number: 490437.

Z-0696-2026
Recall number
Z-0696-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
4,536 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490437; Primary UDI-DI: 04046964833427; Unit of Dose UDI-DI: 04046964833410; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 95 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 128 IN.; Catalog Number: 480231.

Z-0697-2026
Recall number
Z-0697-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
85,176 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 480231; Primary UDI-DI: 04046955083534; Unit of Dose UDI-DI: 04046955083428; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 96 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 3 CARESITE LADS, 131 IN.; Catalog Number: 490274.

Z-0698-2026
Recall number
Z-0698-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
98,568 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490274; Primary UDI-DI: 04046964716621; Unit of Dose UDI-DI: 04046964716614; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 97 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 103 IN.; Catalog Number: 490239.

Z-0699-2026
Recall number
Z-0699-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
5,100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490239; Primary UDI-DI: 04046964716423; Unit of Dose UDI-DI: 04046964716416; Expiration Date: Earliest Exp of Comp or 24mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 98 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107.

Z-0700-2026
Recall number
Z-0700-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
5.900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490088; Primary UDI-DI: 04046964301889; Unit of Dose UDI-DI: 04046964301872; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 490107; Primary UDI-DI: 04046964302145; Unit of Dose UDI-DI: 04046964302138; Expiration Date: Earliest Exp of Comp or 60mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 99 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1500UP, IV ADMINISTRATION SET; Catalog Number: 490070.

Z-0701-2026
Recall number
Z-0701-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
9,500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490070; Primary UDI-DI: 04046964301582; Unit of Dose UDI-DI: 04046964301575; Expiration Date: Earliest Exp of Comp or 60mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 100 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESITE LAD, 130 IN; Catalog Number: 477002. 2. IV ADMIN SET 85 IN.; Catalog Number: 477017.

Z-0702-2026
Recall number
Z-0702-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
22,928 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 477002; Primary UDI-DI: 04046955202713; Unit of Dose UDI-DI: 04046955202706; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 477017; Primary UDI-DI: 04046955203109; Unit of Dose UDI-DI: 04046955203093; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 101 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD.SET W/15 DR 128 IN, EXT SET 9 IN; Catalog Number: 490301.

Z-0703-2026
Recall number
Z-0703-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
31,392 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490301; Primary UDI-DI: 04046964716867; Unit of Dose UDI-DI: 04046964716850; Expiration Date: 36mths from Start Date.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 102 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CARESITE LADS; Catalog Number: 490225.

Z-0704-2026
Recall number
Z-0704-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
122,232 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490225; Primary UDI-DI: 04046964304248; Unit of Dose UDI-DI: 04046964304231; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 103 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.; Catalog Number: 490551.

Z-0705-2026
Recall number
Z-0705-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
4,488 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490551; Primary UDI-DI: 04046955275304; Unit of Dose UDI-DI: 04046955275298; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 104 of 116

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET,3 CARESITE LADS,115 IN.; Catalog Number: 490361.

Z-0706-2026
Recall number
Z-0706-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
6,672 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490361; Primary UDI-DI: 04046964642623; Unit of Dose UDI-DI: 04046964642616; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 105 of 116

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213.

Z-0707-2026
Recall number
Z-0707-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
18,072 untis

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354213; Primary UDI-DI: 04046964182211; Unit of Dose UDI-DI: 04046964182204; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 106 of 116

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564.

Z-0708-2026
Recall number
Z-0708-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
2,352 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490564; Primary UDI-DI: 04046955275588; Unit of Dose UDI-DI: 04046955275571; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 107 of 116

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/2 CARESITE; Catalog Number: 354212.

Z-0709-2026
Recall number
Z-0709-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
162,648 untis

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354212; Primary UDI-DI: 04046964293832; Unit of Dose UDI-DI: 04046964293825; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 108 of 116

RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2 CARESITES; Catalog Number: 375258.

Z-0710-2026
Recall number
Z-0710-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
150,664 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 375258; Primary UDI-DI: 04046955256976; Unit of Dose UDI-DI: 04046955256969; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 109 of 116

SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP W/2 SAFEDAY; Catalog Number: 352635.

Z-0711-2026
Recall number
Z-0711-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
200,917 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352635; Primary UDI-DI: 04046955594948; Unit of Dose UDI-DI: 04046955594931; Expiration Date: 36mths from Start Date.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 110 of 116

SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646.

Z-0712-2026
Recall number
Z-0712-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
554,015 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352646; Primary UDI-DI: 04046955626946; Unit of Dose UDI-DI: 04046955626939; Expiration Date: 36mths from Start Date.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 111 of 116

SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.

Z-0713-2026
Recall number
Z-0713-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
46,250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352604; Primary UDI-DI: 04046964181870; Unit of Dose UDI-DI: 04046964181863; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: NF1251; Primary UDI-DI: 04046964187100; Unit of Dose UDI-DI: 04046964187094; Expiration Date: Earliest Exp of Comp or 60mths. 3. Catalog Number: NF1290; Primary UDI-DI: 04046964187148; Unit of Dose UDI-DI: 04046964187131; Expiration Date: Earliest Exp of Comp or 60mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 112 of 116

ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.

Z-0714-2026
Recall number
Z-0714-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
41,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 352049-C; Primary UDI-DI: 04046964717666; Unit of Dose UDI-DI: 04046964717659; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 375100-C; Primary UDI-DI: 04046964717680; Unit of Dose UDI-DI: 04046964717673; Expiration Date: Earliest Exp of Comp or 60mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 113 of 116

Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. VISTA BASIC PUMP IV SET W/ 15 DROP/ML; Catalog Number: US9923F.

Z-0715-2026
Recall number
Z-0715-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
74,652 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: US9923F; Primary UDI-DI: 04046964838156; Unit of Dose UDI-DI: 04046964838149; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 114 of 116

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE FILTER; Catalog Number: 354214.

Z-0716-2026
Recall number
Z-0716-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 354214; Primary UDI-DI: 04046964182235; Unit of Dose UDI-DI: 04046964182228; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 115 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15DROPS/ML; Catalog Number: 490508.

Z-0717-2026
Recall number
Z-0717-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490508; Primary UDI-DI: 04046955135813; Unit of Dose UDI-DI: 04046955135806; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

device · product 116 of 116

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 110 IN.; Catalog Number: 490566.

Z-0718-2026
Recall number
Z-0718-2026
Initiated
October 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information

1. Catalog Number: 490566; Primary UDI-DI: 04046955275625; Unit of Dose UDI-DI: 04046955275618; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.