Medical Device Recalls
Search 40,358 FDA medical device recalls and enforcement actions. Check if devices you use have been recalled for safety reasons.
Search Recalls
Find FDA medical device recalls by device name, reason, or manufacturer. Covers all enforcement actions since 1930.
Browse by Year
View device recalls by year to see trends in medical device safety enforcement.
Latest Device Recalls
Most recently initiated FDA medical device safety recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2026 | FORWARD Gunshot Wound Kit; Model: AFT-GSW; | Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue a... | Class II | INTEGRATED MEDCRAFT LLC |
| Sep 23, 2026 | HexaVue Focus Integration System, a single, all-in-one system that handles op... | A software issue may result in unintended mismatch of patient information on manually printed ima... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 16, 2026 | TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | Williams Cystoscopic Injection Needles, used for cystoscopic injection into t... | The female Luer lock adapter component in the affected device lots may not have been correctly se... | Class II | Cook Incorporated |
| Sep 16, 2026 | Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
Recalls by Year
FDA medical device recalls initiated per year.
Top Recalling Firms
Companies with the most FDA device recall actions.
| # | Firm | Recalls |
|---|---|---|
| 1 | Zimmer Biomet, Inc. | 875 |
| 2 | MEDLINE INDUSTRIES, LP - Northfield | 812 |
| 3 | Customed, Inc | 682 |
| 4 | Boston Scientific Corporation | 642 |
| 5 | Siemens Medical Solutions USA, Inc | 623 |
| 6 | ICU Medical, Inc. | 605 |
| 7 | Medline Industries, LP | 574 |
| 8 | GE Healthcare, LLC | 474 |
| 9 | Siemens Healthcare Diagnostics, Inc. | 462 |
| 10 | Zimmer, Inc. | 444 |
| 11 | Arrow International Inc | 431 |
| 12 | Olympus Corporation of the Americas | 423 |
| 13 | Baxter Healthcare Corporation | 383 |
| 14 | Biomerieux Inc | 370 |
| 15 | Windstone Medical Packaging, Inc. | 337 |
How It Works
Search Device Recalls
Enter a device name, type, or manufacturer. Our database covers every FDA medical device enforcement action from 1930 to 2026.
Review the Details
See the full recall information including classification level, reason for recall, recalling firm, and whether the device poses serious health risks.
Take Action
If you have a recalled medical device, contact your healthcare provider immediately. Do not attempt to modify or repair the device yourself. Follow the manufacturer's instructions for return or replacement.
Frequently Asked Questions
An FDA medical device recall is an action taken to address a problem with a medical device that violates FDA law. A recall may be initiated by the manufacturer, importer, or FDA itself. Recalls address issues such as software errors, manufacturing defects, labeling problems, sterility failures, and component malfunctions. Medical devices range from simple bandages to complex implantable devices like pacemakers and artificial joints.
Class I is the most serious, there is a reasonable probability that use of the device will cause serious adverse health consequences or death. Class II means the device may cause temporary or medically reversible adverse health effects. Class III is the least serious, unlikely to cause adverse health consequences.
Contact your healthcare provider immediately, especially for implanted devices. Do not remove or modify any implanted device yourself. Follow the recall instructions for returning or replacing the device. Your doctor can determine whether immediate action is needed or if monitoring is sufficient. Report any adverse events to the FDA through MedWatch.
All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. We maintain 40,358 device safety records from 1930 to 2026.