Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 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 1,694 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 7, 2013	Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and...	Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Jun 7, 2013	Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set...	Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe...	Class I	Medtronic MiniMed
Jun 3, 2013	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ...	Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2...	Medtronic is providing Healthcare Professionals with important safety information and patient man...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ...	Medtronic is providing Healthcare Professionals with important safety information and patient man...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2...	Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
Jun 3, 2013	Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm...	The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po...	Class I	Medtronic Neuromodulation
May 28, 2013	INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA,...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, ...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek US...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, I...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek ...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, I...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 3, 2013	PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 20...	ConMed was notified by the contract manufacturer that their wire/connector supplier reported dama...	Class II	ConMed Corporation
May 3, 2013	- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122...	The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ...	Class II	Surgical Instrument Service And Savings, Inc.
Apr 30, 2013	adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes...	TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible trans...	Class II	TZ Medical Inc.
Mar 22, 2013	Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, ...	Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap m...	Class II	Medtronic MiniMed
Mar 13, 2013	Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W...	Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 in...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Mar 13, 2013	Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. ...	Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Sti...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Mar 4, 2013	REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D....	In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff ...	Class I	Medtronic Xomed, Inc.
Feb 27, 2013	Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicat...	Medtronic has found through device testing that if the optional footswitch is not connected to th...	Class II	Medtronic Neuromodulation
Feb 19, 2013	Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopul...	Potential for uncharacteristically rough metal edges to occur along the inner diameter of the met...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Feb 8, 2013	Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ...	There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ...	Class I	Medtronic Neuromodulation
Feb 8, 2013	Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. S...	There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ...	Class I	Medtronic Neuromodulation
Jan 31, 2013	Medtronic O-arm Imaging System Product Usage: image-intensified fluorosco...	Potential failure of the braking system that controls the O-arm Imaging System gantry movement in...	Class II	Medtronic Navigation, Inc.
Dec 3, 2012	Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 3708...	Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), w...	Class II	Medtronic Neuromodulation
Nov 19, 2012	Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA...	Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Nov 13, 2012	The Vertex Max Drill Tube is a component within the Navigated Vertex Max Dril...	Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation Syst...	Class II	Medtronic Navigation, Inc.
Nov 9, 2012	Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ...	Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ...	Class I	Medtronic Neuromodulation
Nov 9, 2012	SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10...	Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ...	Class I	Medtronic Neuromodulation
Sep 19, 2012	Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ...	Firm received reports of difficulty in flushing the graft cover of the delivery system during dev...	Class II	Medtronic Vascular, Inc.
Aug 30, 2012	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 1...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 E...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Jul 11, 2012	Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-0...	A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat an...	Class II	Medtronic Navigation, Inc.
Oct 12, 2010	Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: ...	Software Version 3.1.1 does not meet navigational accuracy.	Class II	Medtronic Navigation, Inc.
Sep 27, 2010	Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ...	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni...	Class II	Medtronic Xomed, Inc.
Sep 27, 2010	Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ...	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni...	Class II	Medtronic Xomed, Inc.
Sep 27, 2010	Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ...	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni...	Class II	Medtronic Xomed, Inc.
Mar 4, 2009	lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014...	Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the ...	Class II	Invatec Llc

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.