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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Oct 30, 2015 RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx ... An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner ... Class II BioHorizons Implant Systems Inc
Apr 16, 2015 Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage... BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of... Class II BioHorizons Implant Systems Inc
Dec 10, 2013 External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx... The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fac... Class II BioHorizons Implant Systems Inc
Nov 19, 2012 Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BI... The cleaning instructions provided may not be sufficient to remove residual contaminants after su... Class II BioHorizons Implant Systems Inc
Nov 19, 2012 AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRM... The cleaning instructions provided may not be sufficient to remove residual contaminants after su... Class II BioHorizons Implant Systems 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.