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Browse Device Recalls

56 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 56 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 56 FDA device recalls.

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DateProductReasonClassFirm
Aug 6, 2012 Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating fo... Although the reported incidence is low, there is the potential for the drill stop to slip on the ... Class II Synthes USA HQ, Inc.
Aug 6, 2012 Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating fo... Although the reported incidence is low, there is the potential for the drill stop to slip on the ... Class II Synthes USA HQ, Inc.
Jul 5, 2012 Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S... There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical caut... Class I Synthes USA HQ, Inc.
Jun 18, 2012 MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for ... Synthes is initiating a Medical Device Labeling Correction following a detailed review of the cur... Class II Synthes USA HQ, Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, 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.