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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jun 4, 2020 | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S SR MRI, Model Number W3SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S DR MRI, Model Number W3DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Patient Connector, Model Number 24967 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | CareLink SmartSync Device Manager, Model Number 24970A | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 30, 2020 | MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 30, 2020 | MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx On... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 30, 2020 | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Mar 18, 2020 | H12+ and patient cable for the H12+ Holter Recorders with the following devic... | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... | Class II | WELCH ALLYN, INC/MORTARA |
| Feb 28, 2020 | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fi... | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that t... | Class II | Argo Medical Technologies Ltd |
| Feb 27, 2020 | CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue numbe... | The wall charger may not properly charge the infusion pump battery. | Class II | CME America LLC |
| Feb 13, 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated power... | Due to programming errors in the Controller, an increase in the set motor parameters can be made ... | Class II | Sunrise Medical (US) LLC |
| Feb 4, 2020 | CareFusion Alaris Syringe Module, Model 8110 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, 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.