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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.