Browse Device Recalls
336 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 336 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 336 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 26, 2021 | Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: ... | Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... | Class II | Medtronic Inc. |
| Feb 26, 2021 | Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: ... | Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... | Class II | Medtronic Inc. |
| Feb 26, 2021 | Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: ... | Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... | Class II | Medtronic Inc. |
| Feb 26, 2021 | Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging:... | Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... | Class II | Medtronic Inc. |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditi... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable ca... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual cha... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| 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 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| 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... |
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.