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.

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Date	Product	Reason	Class	Firm
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
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.

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.