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
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.