Browse Device Recalls

44 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 44 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 44 FDA device recalls.

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DateProductReasonClassFirm
Mar 11, 2016 Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only ... Integra's post QA release review of historical product release test results for Meshed IDRT produ... Class II Integra LifeSciences Corporation
Apr 14, 2015 The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... Class II Integra LifeSciences Corp.
Apr 14, 2015 The Integra Camino ICP Monitor is a compact, portable device for use with Pre... Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 M... Class II Integra LifeSciences Corp.
Apr 14, 2015 The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... Class II Integra LifeSciences Corp.
Dec 19, 2014 The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. ... Through an investigation of complaints, Integra found that there is the possibility for the locki... Class II Integra LifeSciences Corporation
Aug 18, 2014 Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Irel... Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monito... Class II Integra LifeSciences Corp.
Mar 28, 2014 Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number... New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfi... Class II Integra LifeSciences Corporation
Oct 28, 2013 Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Numbe... Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesi... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit R... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Pro... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
May 9, 2013 Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcan... As a result of the investigation into an adverse trend of complaints for reports of misalignment ... Class II Integra LifeSciences Corporation
Mar 28, 2013 Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in sur... Due to the process deviation, product lots in question may have been released with higher levels ... Class II Integra LifeSciences Corporation
Mar 28, 2013 HeliPlug 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 CollaPlug 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 Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absor... Due to the process deviation, product lots in question may have been released with higher levels ... Class II Integra LifeSciences Corporation
Mar 28, 2013 INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recomm... Due to the process deviation, product lots in question may have been released with higher levels ... Class II Integra LifeSciences Corporation
Mar 28, 2013 Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regene... 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 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
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

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.