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 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. |
| 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. |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Dec 12, 2024 | Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 12, 2024 | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Class II | Medtronic Perfusion Systems |
| Dec 10, 2024 | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0... | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to... | Class II | ev3 Inc |
| Dec 4, 2024 | Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150M... | Due to an increase in complaint that the percutaneous reference pin would not fit into the patien... | Class II | Medtronic Navigation, Inc. |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 1, 2024 | Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Nov 1, 2024 | Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Oct 3, 2024 | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Can... | Class II | Medtronic Perfusion Systems |
| Sep 24, 2024 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able ... | Class II | Medtronic Neuromodulation |
| Sep 18, 2024 | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components... | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Class II | Medtronic Neuromodulation |
| Sep 11, 2024 | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Class II | Medtronic Neuromodulation |
| Aug 28, 2024 | MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE HEART CABG CDS, REF CDS983376R | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE OPEN HEART PACK, REF DYNJ66216C | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE OPEN HEART, REF DYNJ904261B | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.