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 |
|---|---|---|---|---|
| May 13, 2026 | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| May 13, 2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 10, 2026 | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 8, 2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... | Class II | Medtronic Neuromodulation |
| Mar 11, 2026 | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... | ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... | Class II | Medtronic, Inc. |
| Feb 13, 2026 | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 530G Insulin Pump (MMT-551, MMT-751) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm Insulin Pump (MMT-712, MMT-715) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 620G Insulin Pump (MMT-1750) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Jan 30, 2026 | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... | Class II | Medtronic MiniMed, Inc. |
| Jan 13, 2026 | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Produ... | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was i... | Class II | Medtronic Perfusion Systems |
| Jan 2, 2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Alphatec Spine, Inc. |
| Jan 2, 2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Alphatec Spine, Inc. |
| Dec 4, 2025 | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210... | Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed a... | Class II | Medtronic Inc |
| Dec 3, 2025 | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and... | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a... | Class II | Medtronic Neuromodulation |
| Nov 20, 2025 | Restore Clinician Programmer Application (CP App), Model A71100 used with the... | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rar... | Class II | Medtronic Neuromodulation |
| Nov 17, 2025 | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ... | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Nov 13, 2025 | InPen App, Model/CFN Number: MMT-8061 (Android Users) | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St... | Class II | Medtronic MiniMed, Inc. |
| Nov 2, 2025 | MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software... | A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr... | Class II | Medtronic MiniMed, Inc. |
| Oct 29, 2025 | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable ... | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of even... | Class II | Medtronic, Inc. |
| Oct 21, 2025 | CareLink Clinic, REF: MMT-7350 | Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... | Class II | Medtronic MiniMed, Inc. |
| Oct 20, 2025 | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instruct... | Class II | Medtronic Perfusion Systems |
| Oct 3, 2025 | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E... | Class II | Medtronic Perfusion Systems |
| Sep 16, 2025 | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could res... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 12, 2025 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that di... | Class II | Medtronic Perfusion Systems |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Jul 17, 2025 | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. ... | Due to out of the box wobble of the driver. | Class II | Medtronic Xomed, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, 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.