Browse Device Recalls

3,528 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,528 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,528 FDA device recalls — Class I.

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DateProductReasonClassFirm
Feb 18, 2026 Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by ... If heating pad is folded while in use, the power density increases in the folded area causing exc... Class I Navajo Manufacturing Company
Feb 16, 2026 Automated Impella Controller (AIC), labeled as the following with correspondi... Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC... Class I Abiomed, Inc.
Feb 13, 2026 DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A,... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-17... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, C... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 12, 2026 Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use Probes may rupture/burst during activation Class I Erbe USA Inc
Feb 12, 2026 Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use Probes may rupture/burst during activation Class I Erbe USA Inc
Feb 12, 2026 Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: ... Probes may rupture/burst during activation Class I Erbe USA Inc
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Jan 27, 2026 Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Dec 29, 2025 WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device... Cyber vulnerability of BLE communication was found by CISA VDP program. Class I WHILL, INC.
Dec 29, 2025 WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is... Cyber vulnerability of BLE communication was found by CISA VDP program. Class I WHILL, INC.
Dec 22, 2025 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Liv... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Cathet... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON ... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 E... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquir... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Nov 26, 2025 MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E;... Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP
Nov 26, 2025 MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP
Nov 26, 2025 MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP
Nov 26, 2025 MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP
Nov 26, 2025 MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP
Nov 26, 2025 MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.
Nov 24, 2025 Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. A certain component of affected devices was not delivered within specification and contained impu... Class I Draeger, Inc.
Nov 24, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... Ophthalmic procedure packs may have incomplete seals affecting sterility. Class I Alcon Research LLC
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.