Browse Device Recalls

319 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 319 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 319 FDA device recalls.

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DateProductReasonClassFirm
Nov 12, 2020 CareLink Personal Software Therapy Management Software Tool for Diabetes Car... Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... Class II Medtronic Inc.
Nov 5, 2020 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... Manufacturing error that may have resulted in a cathode component being out of specification. Al... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jul 15, 2020 The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by pat... As a result of the release of new software version to CareLink Personal website, the IOS app for ... Class II Medtronic Inc.
Jul 13, 2020 Medtronic SynchroMed, Model A10 The previous software application version (1.1.300) is missing a decimal separator (a comma) for ... Class II Medtronic Inc.
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.
Apr 10, 2020 Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 045... Internal testing results showed endotoxin-related test result did not meet specifications for im... Class II Medtronic Inc.
Jan 30, 2020 Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020 Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtroni... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 21, 2019 Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 6, 2019 Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1V... Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 6, 2019 Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 20, 2019 Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... Class II Medtronic Inc.
Mar 4, 2019 Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Produ... The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. Class III Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber ... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD):... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: Versa, Dual chamber rate responsive p... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 MEDTRONIC CARELINK 2090 programmer There is an error in how the programmer calculates and displays the remaining longevity value dur... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamb... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 po... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): ... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2018 Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... Class II Medtronic Inc.
Oct 2, 2018 Medtronic CareLink 2090 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual wit... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 2, 2018 Medtronic CareLink Encore 29901 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual wit... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 7, 2018 Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE,... There is a potential security vulnerability related to the use of the remote controller accessori... Class I Medtronic Inc.
Aug 7, 2018 Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503U... There is a potential security vulnerability related to the use of the remote controller accessori... Class I Medtronic Inc.
Jul 4, 2018 Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. The application may be closed by the operating system without alerting the user the app is no lon... Class II Medtronic Inc.
Jun 21, 2018 Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...

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.