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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
Dec 31, 2025 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... Products were mislabeled as the 6mm product but included the 5 mm product. Class II Centinel Spine, Inc.
Jul 18, 2024 prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis... Class II Centinel Spine, Inc.
Jul 18, 2024 prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog... During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis... Class II Centinel Spine, Inc.
Mar 5, 2021 Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in ske... Centinel Spine learned through five customer complaints that the product was missing the "UP" etc... Class II Centinel Spine, 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.