Browse Device Recalls
36 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 36 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 36 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 10, 2022 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System ... | Potential that insert will be unable to disengage from the vertebral body replacement device/implant | Class II | NuVasive Inc |
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... | Class III | NuVasive Inc |
| Jun 20, 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, H... | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Tra... | Class II | NuVasive Inc |
| Jun 10, 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008... | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal sur... | Class II | NuVasive Inc |
| Feb 13, 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product ... | Post-implantation separation of an actuator end cap component that may expose internal components... | Class II | NuVasive Inc |
| Jan 5, 2009 | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive Inc |
| Jan 5, 2009 | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | NuVasive 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.