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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
May 14, 2020 DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - ... The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Class II Neocis Inc.
May 14, 2020 DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) -... The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Class II Neocis Inc.
May 14, 2020 DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) -... The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Class II Neocis Inc.
Oct 4, 2019 Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance Sy... The Fiducial Array may mismatch their measurement files resulting in failed landmark check. Class II Neocis 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.