Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 12, 2021 | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusabl... | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a... | Class II | Covidien Llc |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Console" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector USB" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Dual USB" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Nov 4, 2021 | GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" | The firm identified that the Vscan Extend device will not power on because of depleted battery, d... | Class II | GE Healthcare, LLC |
| Oct 16, 2021 | Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Oct 16, 2021 | Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Oct 16, 2021 | Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS... | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Oct 16, 2021 | Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS... | VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... | Class II | Western/Scott Fetzer Company |
| Sep 21, 2021 | Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Card... | A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum run... | Class I | Datascope Corp. |
| Sep 8, 2021 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7... | The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b... | Class II | Datascope Corp. |
| Sep 8, 2021 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3... | The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b... | Class II | Datascope Corp. |
| Aug 19, 2021 | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100... | Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... | Class II | Philips Ultrasound Inc |
| Aug 19, 2021 | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100... | Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... | Class II | Philips Ultrasound Inc |
| 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 |
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.