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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.

Clear
DateProductReasonClassFirm
Jan 18, 2022 Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only Incorrect marketing label (25 mm) was applied to product size 20 mm. Class II Merete Medical GmbH
Sep 18, 2020 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) Product may be mislabeled. Class II Merete Medical GmbH
Sep 18, 2020 OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails Product may be mislabeled. Class II Merete Medical GmbH
Sep 18, 2020 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) Product may be mislabeled. Class II Merete Medical GmbH
Sep 18, 2020 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) Product may be mislabeled. Class II Merete Medical GmbH

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.