Browse Device Recalls

279 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 279 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 279 FDA device recalls.

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Date	Product	Reason	Class	Firm
Mar 28, 2013	DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matri...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbab...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant f...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorb...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	Absorbable Collagen Sponge Provided As Intermediate to Another Company	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of perip...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the m...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix ...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane i...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in su...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable ...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorba...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Mar 28, 2013	Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba...	Due to the process deviation, product lots in question may have been released with higher levels ...	Class II	Integra LifeSciences Corporation
Feb 12, 2013	Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in ...	Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions alrea...	Class II	Integra LifeSciences Corp.
Feb 1, 2013	Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and can...	The firm has received numerous complaints of the cannulated screw driver tip breaking during surg...	Class II	Integra LifeSciences Corp.
Jan 7, 2013	Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecon...	There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the...	Class II	Integra LifeSciences Corp.
Dec 21, 2012	MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integ...	Integra determined there is a possibility that the Base Units may break during use.	Class II	Integra LifeSciences Corp.
Dec 10, 2012	Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning...	Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occu...	Class II	Integra LifeSciences Corp.
Nov 5, 2012	MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The ...	An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified v...	Class II	Integra LifeSciences Corporation
Nov 5, 2012	MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) i...	An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified v...	Class II	Integra LifeSciences Corporation
Aug 9, 2012	Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head R...	T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-...	Class II	Integra LifeSciences Corporation
Aug 9, 2012	Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotac...	T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-...	Class II	Integra LifeSciences Corporation
Jun 7, 2012	Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit...	Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve...	Class III	Integra LifeSciences Corp. d.b.a. Integra Pain ...
Apr 4, 2012	Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. In...	The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the de...	Class II	Integra LifeSciences Corp
Feb 9, 2012	Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive...	Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during su...	Class II	Integra LifeSciences Corp.
Oct 11, 2011	Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is...	The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l f...	Class II	Integra LifeSciences Corp.
Oct 11, 2011	Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft ...	The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for...	Class II	Integra LifeSciences Corp.

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.