Official device enrichment

Separate sourced root-cause wording from missing evidence.

This laboratory joins device enforcement products to public FDA device-enrichment records through documented exact identifiers. It preserves official wording and never turns an absent or conflicting join into a conclusion.

Four explicit evidence outcomes

What each state means

Global device-product counts

Sourced 32,075 products: At least one exact joined official device-enrichment row contains root-cause wording. The wording is preserved as an official fact, not an app conclusion.
? Unknown 7,441 products: An exact joined enrichment record exists, but none supplies supported root-cause wording. This does not mean FDA reported that the cause is unknown.
Unavailable 3 products: No public enrichment row could be joined through the supported exact identifiers, or the enrichment source itself was unavailable. This is not evidence of no root cause.
Ambiguous 0 products: Official identifier candidates conflict. Recall Observatory preserves the conflict and does not select a candidate or synthesize root-cause wording.

Coverage and provenance

Device sources represented

Device enrichment openFDA Device Recall · event_date_initiated coverage June 01, 1997–June 30, 2026 Official source · published July 16, 2026 07:05
Enforcement 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. Official source · published July 16, 2026 07:03

Enforcement bounds use FDA report dates; device-enrichment bounds use FDA event_date_initiated. A product's recall-initiation date can precede enforcement report-date coverage.

Inspect corpus status

Exact official wording

Root-cause wording register

40 distinct wordings

Counts use distinct recalled products and exact recall events. Wording is grouped only by byte-for-byte database equality; similar phrases are not normalized, merged, ranked, or interpreted as equivalent causes.

Exact official device root-cause wording counts
Official root-cause wording	Recalled products	Exact events
Device Design	5,544	2,055
Process control	4,983	1,836
Nonconforming Material/Component	4,049	1,363
Software design	2,469	1,529
Packaging	1,376	150
Component design/selection	1,096	440
Other	984	377
No Marketing Application	941	214
Packaging process control	846	256
Process change control	807	277
Error in labeling	790	298
Process design	790	322
Employee error	749	410
Package design/selection	636	117
Labeling design	631	223
Equipment maintenance	505	126
Labeling Change Control	485	268
Material/Component Contamination	423	165
Labeling mix-ups	401	260
Component change control	391	154
Use error	316	142
Mixed-up of materials/components	290	180
Radiation Control for Health and Safety Act	274	181
Storage	270	42
Vendor change control	258	66
Packaging change control	255	72
Labeling False and Misleading	253	116
Software Design Change	209	145
Environmental control	186	36
Software change control	159	89
Incorrect or no expiration date	144	59
Software Manufacturing/Software Deployment	137	84
Software design (manufacturing process)	100	62
Reprocessing Controls	88	28
Manufacturing material removal	82	21
Software in the Use Environment	82	60
Release of Material/Component prior to receiving test results	40	28
Finished device change control	26	15
PMA	6	3
Counterfeit	4	4

Current device enforcement corpus

39,519 recalled products

14,800 exact events

The selected filter changes this product ledger and its product/event summary only. The four-state overview and exact-wording register remain global corpus context.

Device enforcement product

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

Z-2400-2026 · initiated May 27, 2026

Sourced

Recalling firm: Inter-Med Llc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99105

Review official root-cause evidence and provenance

Official device-enrichment wording

Labeling mix-ups

Device enforcement product

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System

Z-2574-2026 · initiated May 27, 2026

Sourced

Recalling firm: Dexcom, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98968

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Z-2523-2026 · initiated May 26, 2026

Sourced

Recalling firm: Philips North America Llc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99084

Review official root-cause evidence and provenance

Official device-enrichment wording

Process control

Device enforcement product

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Z-2522-2026 · initiated May 26, 2026

Sourced

Recalling firm: Philips North America Llc
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99084

Review official root-cause evidence and provenance

Official device-enrichment wording

Process control

Device enforcement product

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Z-2602-2026 · initiated May 22, 2026

Unknown

Recalling firm: Abiomed, Inc.
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99002

Review official root-cause evidence and provenance

? Unknown

An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.

Device enforcement product

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

Z-2599-2026 · initiated May 22, 2026

Unknown

Recalling firm: Abiomed, Inc.
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99002

Review official root-cause evidence and provenance

? Unknown

An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.

Device enforcement product

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

Z-2600-2026 · initiated May 22, 2026

Unknown

Recalling firm: Abiomed, Inc.
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99002

Review official root-cause evidence and provenance

? Unknown

An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.

Device enforcement product

Medtronic Harmony Delivery Catheter System

Z-2624-2026 · initiated May 22, 2026

Sourced

Recalling firm: Medtronic Heart Valves Division
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99031

Review official root-cause evidence and provenance

Official device-enrichment wording

Process control

Device enforcement product

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Z-2601-2026 · initiated May 22, 2026

Unknown

Recalling firm: Abiomed, Inc.
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99002

Review official root-cause evidence and provenance

? Unknown

An exact official-identifier join exists, but the joined records contain no supported root-cause wording. This is not an FDA finding of an unknown cause.

Device enforcement product

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Z-2625-2026 · initiated May 22, 2026

Sourced

Recalling firm: Hamilton Medical AG
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99035

Review official root-cause evidence and provenance

Official device-enrichment wording

Process design

Device enforcement product

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

Z-2514-2026 · initiated May 21, 2026

Sourced

Recalling firm: BD SWITZERLAND SARL
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98855

Review official root-cause evidence and provenance

Official device-enrichment wording

Device Design

Device enforcement product

MOSAIQ Oncology Information System

Z-2406-2026 · initiated May 21, 2026

Sourced

Recalling firm: Elekta, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98980

Review official root-cause evidence and provenance

Official device-enrichment wording

Software design

Device enforcement product

Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A

Z-2545-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device

Z-2549-2026 · initiated May 21, 2026

Sourced

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99119

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 11) TRIPLE LUMEN CVC 20CM BUNDLE W/O SUTURE, Model Number: ECVC7290; 12) AVA HIGH FLOW, Model Number: ECVC3720; 13) 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC8215; 14) CENTRAL LINE INSERTION BUNDLE, Model Number: ECVC2080; 15) 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; 16) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC6505; 17) VANTEX 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC02; 18) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 19) INTROFLEX 8.5FR. 1L CVC BUNDLE, Model Number: CMPI851LBA; 20) INTROFLEX 5F, 1L, TB, US, BAS, Model Number: STCVC49US; 21) CVC BUNDLE, Model Number: ECVC8090; 22) TRIPLE LUMEN INSERTION KIT W/CATHETER, Model Number: ECVC2885; 23) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 24) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 25) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC6845; 26) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; 27) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 28) CVC INSERTION BUNDLE, Model Number: ECVC1120; 29) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 30) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 31) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC8075; 32) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number: ECVC2745; 33) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC7945; 34) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750

Z-2536-2026 · initiated May 21, 2026

Sourced

Recalling firm: Medline Industries, LP
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99162

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222

Z-2666-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device

Z-2548-2026 · initiated May 21, 2026

Sourced

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
FDA status: Ongoing
Evidence destination: Event 99119

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Device enforcement product

Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);

Z-2669-2026 · initiated May 21, 2026

Sourced

Recalling firm: Laborie Medical Technologies Corp
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 98876

Review official root-cause evidence and provenance

Official device-enrichment wording

Device Design

Device enforcement product

CRE Pro Wireguided 8-10mm 240cm

Z-2627-2026 · initiated May 21, 2026

Sourced

Recalling firm: Boston Scientific Corporation
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99067

Review official root-cause evidence and provenance

Official device-enrichment wording

Package design/selection

Device enforcement product

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 The Power-Trialysis" Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Z-2660-2026 · initiated May 21, 2026

Sourced

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
FDA status: Ongoing
Evidence destination: Event 99096

Review official root-cause evidence and provenance

Official device-enrichment wording

Nonconforming Material/Component

Evidence boundary: this page reports official device-enrichment wording and exact join outcomes. It does not infer a root cause, merge similar phrases, or treat missing enrichment as evidence of no root cause. Review the full methodology