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 |
|---|---|---|---|---|
| Aug 28, 2024 | MEDLINE KIT CV I II, REF DYNJ906071B | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 22, 2024 | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stea... | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navig... | Class II | Medtronic Navigation, Inc. |
| Aug 21, 2024 | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading t... | Class II | Medtronic Neuromodulation |
| Jul 31, 2024 | MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1... | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... | Class I | Medtronic MiniMed, Inc. |
| Jul 31, 2024 | MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582,... | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... | Class I | Medtronic MiniMed, Inc. |
| Jul 31, 2024 | MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G I... | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... | Class I | Medtronic MiniMed, Inc. |
| Jul 11, 2024 | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... | Class II | Medtronic Inc. |
| Jul 9, 2024 | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... | Class II | Medtronic Perfusion Systems |
| Jul 5, 2024 | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Class II | Medtronic Xomed, Inc. |
| Jun 24, 2024 | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... | Potential for false negative response on the NIM Vital Nerve Monitoring System | Class I | Medtronic Xomed, Inc. |
| Jun 17, 2024 | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programm... | A subset of the handsets within the kit may not be able to complete the pairing process with the ... | Class II | Medtronic Neuromodulation |
| May 16, 2024 | TourniKwik Tourniquet Set (CFN 79012) | Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. | Class II | Medtronic Perfusion Systems |
| May 15, 2024 | A610 Clinician Programmer (CP) Software Application (app) with the following ... | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI ... | Class II | Medtronic Neuromodulation |
| May 10, 2024 | Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 878... | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of th... | Class II | Medtronic Neuromodulation |
| Apr 26, 2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... | Class II | Medtronic Navigation, Inc.-Littleton |
| Apr 16, 2024 | EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defib... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardi... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defib... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardiover... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardiover... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardi... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Product not distributed in the US. Implantable Cardioverter Defibrillators: ... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardiover... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibr... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibr... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibr... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defib... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Mar 28, 2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Class II | Medtronic Neuromodulation |
| Mar 26, 2024 | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either... | Class I | Medtronic Navigation, Inc. |
| Mar 19, 2024 | Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Clearview Blower/Mister, Model Number 22120 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
| Mar 19, 2024 | Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
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.