Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Produc... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 -... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Prod... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 -... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Produc... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Pr... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Prod... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usag... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Produ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usag... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Pr... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm... Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the b... Class II Arrow International Inc
Mar 8, 2021 BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Pro... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product ... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 8, 2021 BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usa... There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... Class II BIOTRONIK Inc
Mar 5, 2021 Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cuttin... Investigations related to customer complaints received for particulate matter inside of the Surgi... Class II Covidien
Mar 2, 2021 Consist of a distal connection mechanism (either standard Terumo Ball Quick C... There is a potential for the stainless steel locking plates on the device's sternal retractor loc... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2021 Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... Class II Abiomed, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... Class I Heartware, Inc.
Feb 25, 2021 Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the col... Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... Class II Fenwal Inc
Feb 25, 2021 Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in... Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... Class II Fenwal Inc
Feb 25, 2021 Amicus Exchange Kit - Product Usage: intended for use in the collection of bl... Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... Class II Fenwal Inc
Feb 22, 2021 SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for s... There is a potential presence of particulate matter in the D-Vial. Class II Sirtex Medical Limited
Feb 22, 2021 The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 22, 2021 ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... Class II DePuy Orthopaedics, Inc.
Feb 3, 2021 Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Feb 3, 2021 Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 21, 2021 Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... Class II G & H Wire Company
Jan 7, 2021 Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, La... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, La... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC

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.