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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 30, 2023 | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... | Class I | Busse Hospital Disposables, Inc. |
| Nov 30, 2023 | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... | Class I | Busse Hospital Disposables, Inc. |
| Nov 30, 2023 | Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. N... | Class I | Busse Hospital Disposables, Inc. |
| Oct 21, 2022 | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Oct 21, 2022 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, 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 | 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 | 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 | 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. |
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.