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Browse Device Recalls

63 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 63 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 63 FDA device recalls.

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DateProductReasonClassFirm
Feb 22, 2022 Lumbar Tray Catalog 1091 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Joint Injection Tray Catalog Number: 8561R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Pump Refill Kit Catalog Number: 7347R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Procedural Accessory Kit Catalog Number: 9665R2 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Core Biopsy Tray Catalog Number: 8673R4 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Pain Tray Catalog Number: 9883 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Single Shot Epidural Tray Catalog Number: 8417 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Nerve Block Tray Catalog Number: 8415 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 3.2MM Pellet Insertion Tray Catalog Number: B9743 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, 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.