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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Mar 31, 2019 Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra ... Stability did not meet acceptance criteria for visual appearance during mixing and force vs. disp... Class II Integra Limited
Mar 1, 2019 Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - ... Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... Class II Integra Limited
Mar 1, 2019 Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - ... Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... Class II Integra Limited
Mar 1, 2019 Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - P... Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... Class II Integra Limited
Sep 10, 2013 Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Ca... Integra LifeSciences has identified through an internal evaluation that in order to comply with U... Class II Integra Limited
Jul 17, 2013 Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hard... As a result of complaint investigations it was identified that there is a potential that the Leyl... Class II Integra Limited
Jul 27, 2012 The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... Class II Integra Limited
Jul 27, 2012 The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ B... An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel ... Class II Integra Limited
May 23, 2012 Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(... The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal co... Class II Integra Limited

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.