Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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... |
| May 12, 2020 | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c... | Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) | Class I | Medtronic Vascular Galway DBA Medtronic Ireland |
| 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 24, 2020 | Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA 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. |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 -... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 -... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Mar 26, 2020 | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Nonconforming product; length of the product measured shorter than the labeled length. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 11, 2020 | Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm | Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve... | Class II | MEDTRONIC ATS MEDICAL, 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... |
| Jan 28, 2020 | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Lar... | Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles ... | Class II | Medtronic, PLC |
| Jan 14, 2020 | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used ... | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... | Class II | Medtronic CoreValve LLC |
| Jan 14, 2020 | Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a p... | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... | Class II | Medtronic CoreValve LLC |
| Dec 5, 2019 | Mazor X Surgical System Positioner Type II, REF: ASM0214-02 | There is a potential for the surgical system to detach from the operational room table unexpected... | Class II | Medtronic Navigation, Inc. |
| 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. |
| Nov 15, 2019 | O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 | Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ... | Class II | Medtronic Navigation, Inc.-Littleton |
| Nov 14, 2019 | Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 | Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in t... | Class II | Medtronic Perfusion Systems |
| Nov 13, 2019 | Lamicel 20PK 3MM INTL Cervical dilator | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II | Medtronic Xomed, Inc. |
| Nov 13, 2019 | Lamicel 20PK 5MM INTL | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II | Medtronic Xomed, Inc. |
| Nov 13, 2019 | Lamicel 10PK 10MM INTL | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II | Medtronic Xomed, Inc. |
| Oct 30, 2019 | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... | Class II | Medtronic Navigation, Inc. |
| Oct 30, 2019 | Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... | Class II | Medtronic Navigation, Inc. |
| Oct 30, 2019 | Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... | Class II | Medtronic Navigation, Inc. |
| Oct 11, 2019 | Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 | There is a potential for the presence of a foreign particle inside the pump motor assembly which ... | Class I | Medtronic Neuromodulation |
| 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... |
| Sep 3, 2019 | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... | Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Sep 3, 2019 | Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... | Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Aug 28, 2019 | NavLock Tracker *** Rx Only | Product was incorrectly assembled which could affect navigation accuracy of the device. | Class II | Medtronic Navigation, Inc. |
| Aug 9, 2019 | Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... | Class I | Medtronic Navigation, Inc. |
| 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... |
| Jul 8, 2019 | Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: ... | The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VC... | Class II | Medtronic Navigation, Inc. |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
| Jun 27, 2019 | Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT... | The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... | Class II | Medtronic MiniMed |
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.