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 |
|---|---|---|---|---|
| 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. |
| Jan 14, 2021 | PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 def... | Due to complaints received regarding missing lid magnets which may result in premature battery de... | Class II | Physio-Control, Inc. |
| Jan 6, 2021 | Infusion Pump | Battery performance issues related to prolonged storage. | Class II | Baxter Healthcare Corporation |
| Jan 6, 2021 | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663... | Due to unqualified "design verification" batteries being shipped to customers. | Class II | Respironics California, LLC |
| Dec 28, 2020 | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 m... | Potential for the battery to lose its ability to be recharged. | Class II | Baxter Healthcare Corporation |
| Dec 2, 2020 | EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;... | Accelerated battery depletion may result in a need for device replacement earlier than expected. | Class II | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod... | Accelerated battery depletion may result in a need for device replacement earlier than expected. | Class II | Boston Scientific Corporation |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: inte... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 16, 2020 | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... | In-house lab observations and customer reports of overheating and/or thermal damage to the batter... | Class II | Covidien Llc |
| Sep 26, 2020 | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 us... | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... | Class III | Advanced Bionics, LLC |
| Sep 26, 2020 | AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 us... | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... | Class III | Advanced Bionics, LLC |
| Sep 10, 2020 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump ... | Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump bat... | Class II | Tandem Diabetes Care Inc |
| Aug 25, 2020 | Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigat... | The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery ... | Class II | Genicon, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8000 modular infusion pump and monitoring system | If one or more screws or washers are loose or missing causing the battery not to be properly secu... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8015. modular infusion pump and monitoring system | If one or more screws or washers are loose or missing causing the battery not to be properly secu... | Class I | CareFusion 303, Inc. |
| Jun 18, 2020 | Phillips Charging Station, Product #: 989803191021 - Product Usage: This char... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Prod... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, 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.