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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Sep 17, 2015 Disposable Paper Filter for Sterilization Containers Paper, Medical Access... Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise ... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) R... Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Ti... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot... Potential for implant damage, implant cracking off/breaking intra-operatively. Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implan... Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, ... Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion... Class II Stryker Craniomaxillofacial Division
Jul 30, 2013 Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-439... Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This coul... Class II Stryker Craniomaxillofacial Division

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.