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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98154

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

Open FDA event record

Event summary

Timeline bucket
November 26, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medline Industries, LP

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

12 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 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B

Z-1049-2026
Recall number
Z-1049-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

UDI/DI 10889942695911 (EA) 40889942695912 (CA), Lot Numbers: 25JMC398

Distribution pattern

US Nationwide distribution.

device · product 2 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.

Z-1050-2026
Recall number
Z-1050-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
633 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100; Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445; Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657; Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924; Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937; Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.

Distribution pattern

US Nationwide distribution.

device · product 3 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.

Z-1051-2026
Recall number
Z-1051-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843; Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327; Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.

Distribution pattern

US Nationwide distribution.

device · product 4 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

Z-1052-2026
Recall number
Z-1052-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU DYNJ0785864R, UDI/DI 10195327656454 (EA) 40195327656455 (CA), Lot Number 25HMB184; Medline kit SKU DYNJ0792607R, UDI/DI 10198459503023 (EA) 40198459503024 (CA). Lot number 25JMH400.

Distribution pattern

US Nationwide distribution.

device · product 5 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B

Z-1053-2026
Recall number
Z-1053-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.

Distribution pattern

US Nationwide distribution.

device · product 6 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A

Z-1054-2026
Recall number
Z-1054-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

UDI/DI 10193489587869 (EA) 40193489587860 (CS), Lot Number 25HBQ850

Distribution pattern

US Nationwide distribution.

device · product 7 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.

Z-1055-2026
Recall number
Z-1055-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
3045 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB125; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB400; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25JDB835; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA036; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA248; Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25IDA545; Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25JDB867; Medline kit SKU ACC010525C, UDI/DI 10198459027765 (EA) 40198459027766 (CS), Lot number 25KDA768; Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25HDB656; Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25IDA638; Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25JDA666; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25HDA878; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA087; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA817; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25JDB317; Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25IBL412; Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25KBK165; Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25IMD671; Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25JMG868; Medline kit SKU DYKS1192C, UDI/DI 10193489849707 (EA) 40193489849708 (CS), Lot number 25KME757; Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25HBF059; Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25JBU391; Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25IBT744; Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25KBG976; Medline kit SKU DYKS1248, UDI/DI 10193489305708 (EA) 40193489305709 (CS), Lot number 25JBS281; Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBJ008; Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBV936; Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25IBB540; Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25HBF086; Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25IBF923; Medline kit SKU DYKS1324, UDI/DI 10193489969962 (EA) 40193489969963 (CS), Lot number 25IBR790; Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25HBF087; Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25IBS865; Medline kit SKU DYNDH1161A, UDI/DI 10889942731299 (EA) 40889942731290 (CS), Lot number 25HBG750; Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25GMK728; Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25HMI417;

Distribution pattern

US Nationwide distribution.

device · product 8 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.

Z-1056-2026
Recall number
Z-1056-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
5314 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25JBB147; Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25KBL305; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25HBT834; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25IBJ757; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25JBJ557; Medline kit SKU DYKS1372C, UDI/DI 10195327373504 (EA) 40195327373505 (CS), Lot Number 25JLA480; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25HBI335; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25IBE523; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25JBM702; Medline kit SKU DYNDV2464A, UDI/DI 10195327065911 (EA) 40195327065912 (CS), Lot Number 25IBV942.

Distribution pattern

US Nationwide distribution.

device · product 9 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.

Z-1057-2026
Recall number
Z-1057-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
11173 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25HBB410; Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25HBE055; Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25HBF057; Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25HBI512; Medline kit SKU DYKS2056A, UDI/DI 10198459467493 (EA) 40198459467494 (CS), Lot Number 25HBK906; Medline kit SKU DYKS2074, UDI/DI 10198459399893 (EA) 40198459399894 (CS), Lot Number 25HBV987; Medline kit SKU DYKS2083, UDI/DI 10198459435126 (EA) 40198459435127 (CS), Lot Number 25HLA076; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25HLA432; Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25HLA829; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMB303; Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25HMB948; Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25HMC488; Medline kit SKU DYKS1507B, UDI/DI 10198459489372 (EA) 40198459489373 (CS), Lot Number 25HMD440; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMF480; Medline kit SKU DYKS1130B, UDI/DI 10198459377129 (EA) 40198459377120 (CS), Lot Number 25IBC508; Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25IBI706; Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25IBK720; Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS), Lot Number 25IBL590; Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25IBL885; Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25IBQ969; Medline kit SKU DYKS1518A, UDI/DI 10198459032448 (EA) 40198459032449 (CS), Lot Number 25IBU385; Medline kit SKU DYKS1489F, UDI/DI 10198459291272 (EA) 40198459291273 (CS), Lot Number 25IBW167; Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS), Lot Number 25ILA943; Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS), Lot Number 25ILA944; Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS), Lot Number 25IME692; Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25JBB244; Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25JBC342; Medline kit SKU DYKS1551B, UDI/DI 10198459347702 (EA) 40198459347703 (CS), Lot Number 25JBE269; Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25JBE865; Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS), Lot Number 25JBG502; Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25JBJ439; Medline kit SKU DYKS2076, UDI/DI 10198459399732 (EA) 40198459399733 (CS), Lot Number 25JBJ451; Medline kit SKU DYKS1263G, UDI/DI 10198459557330 (EA) 40198459557331 (CS), Lot Number 25JBL575; Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25JBO961; Medline kit SKU DYKS1482A, UDI/DI 10198459011368 (EA) 40198459011369 (CS), Lot Number 25JBR391; Medline kit SKU DYKS1382A, UDI/DI 10195327482602 (EA) 40195327482603 (CS), Lot Number 25JBS091; Medline kit SKU DYKS1580, UDI/DI 10198459024320 (EA) 40198459024321 (CS), Lot Number 25JBU194; Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25JBU341; Medline kit SKU DYKS1325A, UDI/DI 10195327549343 (EA) 40195327549344 (CS), Lot Number 25JBU577; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25JLA660; Medline kit SKU DYKS1458F, UDI/DI 10198459477942 (EA) 40198459477943 (CS), Lot Number 25JLA986; Medline kit SKU DYKS1416F, UDI/DI 10198459508561 (EA) 40198459508562 (CS), Lot Number 25JLB077; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25JMD403; Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25JMD404; Medline kit SKU DYKS1093B, UDI/DI 10198459544545 (EA) 40198459544546 (CS), Lot Number 25JMF248; Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25JMH456; Medline kit SKU DYKS2103, UDI/DI 10198459550539 (EA) 40198459550530 (CS), Lot Number 25JML466; Medline kit SKU DYKS2024A, UDI/DI 10198459547201 (EA) 40198459547202 (CS), Lot Number 25KBC077; Medline kit SKU DYKS1128C, UDI/DI 10195327549374 (EA) 40195327549375 (CS), Lot Number 25KBH159; Medline kit SKU DYKS1379B, UDI/DI 10195327387433 (EA) 40195327387434 (CS), Lot Number 25KBL301; Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25KLA016; Medline kit SKU DYKS1468, UDI/DI 10195327411213 (EA) 40195327411214 (CS), Lot Number 25KLA028; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25KLA029; Medline kit SKU DYKS1337D, UDI/DI 10198459078415 (EA) 40198459078416 (CS), Lot Number 25KLA107; Medline kit SKU DYKS1467B, UDI/DI 10198459025648 (EA) 40198459025649 (CS), Lot Number 25KME034; Medline kit SKU DYKS2074A, UDI/DI 10198459528651 (EA) 40198459528652 (CS), Lot Number 25KME090.

Distribution pattern

US Nationwide distribution.

device · product 10 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.

Z-1058-2026
Recall number
Z-1058-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
1725 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU DYKS1339B, UDI/DI 10195327386726(EA) 40195327386727 (CS) , Lot Number 25HMC849; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25IMG807; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25JMF937; Medline kit SKU DYKS1359B, UDI/DI 10195327566449(EA) 40195327566440 (CS) , Lot Number 25JMD518; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25HMD322; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25JMG543.

Distribution pattern

US Nationwide distribution.

device · product 11 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935

Z-1059-2026
Recall number
Z-1059-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

UDI/DI 10884389725092 (EA) 40884389725093 (CS), Lot number 25IBC144

Distribution pattern

US Nationwide distribution.

device · product 12 of 12

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.

Z-1060-2026
Recall number
Z-1060-2026
Initiated
November 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
338 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Code information

Medline kit SKU DYNJ0395085V,UDI/DI 10198459313745 (EA) 40198459313746 (CS), Lot Number 25HMC337; Medline kit SKU DYNJ66311C,UDI/DI 10198459364556 (EA) 40198459364557 (CS), Lot Number 25KBG419; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25IBU284; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25KBJ623; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25HBU964; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25IBV819; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25KBF028.

Distribution pattern

US Nationwide distribution.