Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
Feb 23, 2022 Artis Q.zen ceiling, Model Number 10848354 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q biplane, Model Number 10848282 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q.zen biplane, Model Number 10848355 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee ceiling, Model Number 10094137 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q floor, Model Number 10848280 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee biplane MN, Model Number 10094143 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee multi-purpose, Model Number 10094139 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee biplane, Model Number 10094141 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q.zen floor, Model Number 10848353 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q zeego, Model Number 10848283 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q ceiling, Model Number 10848281 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee floor MN, Model Number 10094142 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 22, 2022 Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Illumina NextSeq 550Dx, REF: 20005715, CE, IVD There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection... Class II Illumina, Inc.
Feb 22, 2022 Single Shot Epidural Tray Catalog 1165 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Epidural Tray Catalog 1577 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 MBB Tray Catalog Number: 9882 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalo... 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: B7345R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 CVC Dressing Change Kit Catalog Number: 2491R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Epidural Tray Catalog 1307 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Cervical Tray Catalog Number: 3765R2 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 - 18G Catalog Number: 8139R2 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: B9807 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 1292 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Universal Nerve Block Tray Catalog Number: 9779 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Procedure Tray Catalog 1065 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Bone Marrow Biopsy Tray Catalog Number: 8917R1 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: B1144 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 with Large Gloves Catalog Number: B1363R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Pellet Insertion Tray Catalog Number: B1654 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Stereo Breast Biopsy Tray Catalog Number: 2383R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Cervical Tray Catalog 1089 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1 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 with Medium Gloves Catalog Number: B1365R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Philips Hemodynamic Application, Model Number 722463, Software Version Number... When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode ... Class II Philips North America Llc
Feb 22, 2022 Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1 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 with Large Gloves Catalog Number: B1363 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362 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: 6796R3 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Universal Tray Catalog 1567 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: 6797R2 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: 9342 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1 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.