Browse Device Recalls
1,680 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,680 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 1,680 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 17, 2025 | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 16, 2025 | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design e... | Class II | Medtronic MiniMed, Inc. |
| May 27, 2025 | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices m... | Class II | Medtronic Navigation, Inc.-Boxborough |
| May 7, 2025 | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... | Class II | Medtronic MiniMed, Inc. |
| Apr 29, 2025 | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-... | Class II | Medtronic, Inc. |
| Apr 3, 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets havin... | Class II | Medtronic Neuromodulation |
| Mar 10, 2025 | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; ... | Nerve Monitoring System with certain software versions has potential for increased stimulus artif... | Class II | Medtronic Xomed, Inc. |
| Mar 4, 2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with... | There is a software issue that can permanently disable communication with an implantable neurosti... | Class II | Medtronic Neuromodulation |
| Mar 4, 2025 | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... | Insulin pens may have been incorrectly assembled therefore users could experience the following: ... | Class II | Medtronic MiniMed, Inc. |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medline medical procedure kits, containing Medtronic Aortic Root Cannula | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 5, 2025 | Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA... | Unexpected loose material in the male luer used in the aortic root cannula has been identified. P... | Class I | Medtronic Perfusion Systems |
| Jan 31, 2025 | MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm insulin pump, REF: MMT-754 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 620G (MMT-1750) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm REF: MMT-712 and MMT-715 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 30, 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... | Class I | Micro Therapeutics, 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.