Browse Device Recalls

1,398 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,398 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 1,398 FDA device recalls in NY.

Clear
DateProductReasonClassFirm
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 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.
Feb 22, 2022 I.V. Start Kit Catalog 8172 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Port Tray Catalog 7607 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Sterile Epidural Tray Catalog Number: 6259R2 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: B1352R1 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 with Medium Gloves" Catalog Number: B1351 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1 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: 6183R1 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: 3764R2 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog numbe... Potential for falsely elevated hCG results due to sample carryover in serum and urine patient sa... Class II Siemens Healthcare Diagnostics, Inc.
Feb 22, 2022 Universal Nerve Block Tray Catalog Number: 9818 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
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.
Feb 17, 2022 LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, produc... Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients ... Class II Kaneka America Corp
Feb 11, 2022 RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayS... Incorrect source to skin or surface distance (SSD) calculation may result in dose error when usin... Class II RaySearch America 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.