Browse Device Recalls

723 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 723 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 723 FDA device recalls.

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DateProductReasonClassFirm
Jun 23, 2021 Covidien Sonicision Reusable Generator-converts electrical power from the bat... Potential for a manufacturing assembly error-may result in a non-functional audio indicator of de... Class II Covidien Llc
Jun 10, 2021 OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and ... There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplet... Class II GE OEC Medical Systems, Inc
Jun 10, 2021 OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product... There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplet... Class II GE OEC Medical Systems, Inc
Jun 3, 2021 Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f)... Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... Class II Boston Scientific Corporation
Jun 3, 2021 VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... Class II Boston Scientific Corporation
Jun 3, 2021 VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) ... Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... Class II Boston Scientific Corporation
Jun 3, 2021 INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f)... Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... Class II Boston Scientific Corporation
Jun 3, 2021 INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... Class II Boston Scientific Corporation
Jun 3, 2021 INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... Class II Boston Scientific Corporation
May 27, 2021 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele... Telepack may not power on when using the 3AA battery cradle. Class III Mindray DS USA, Inc. dba Mindray North America
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 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
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 26, 2021 Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Alarm Adapter, Product Number: 1450 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 142... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Monitor Data Cable, Product Number: 1575 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IF... Class II Heartware, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompani... IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling ... Class II Heartware, 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.