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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jun 19, 2023 ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to gui... Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request Class II Materialise N.V.
Apr 26, 2023 MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... The wrong tibia guide was included intended for a different patient case. Class II Materialise N.V.
Jul 17, 2020 Match Point System The Match Point System is intended to by uses as a surg... The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly i... Class II Materialise N.V.
Feb 3, 2020 TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD... Custom surgical kits contain a plate different than indicated by the package labeling. Class II Materialise N.V.
Feb 3, 2020 TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Custom surgical kits contain a plate different than indicated by the package labeling. Class II Materialise N.V.
Sep 23, 2015 Signature Patient-Specific Surgical Guides; patient specific instruments used... Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because ... Class II Materialise N.V.
Feb 4, 2015 Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Spec... Images belonging to a different patient were used for the production of the patient specific surg... Class II Materialise N.V.

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.