Medical Device Recalls
Search 39,949 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 |
|---|---|---|---|---|
| Aug 18, 2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Doubl... | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Class II | Olympus Corporation of the Americas |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2026 | 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-51... | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 7, 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
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 | 639 |
| 5 | Siemens Medical Solutions USA, Inc | 623 |
| 6 | ICU Medical, Inc. | 596 |
| 7 | Medline Industries, LP | 532 |
| 8 | GE Healthcare, LLC | 474 |
| 9 | Siemens Healthcare Diagnostics, Inc. | 461 |
| 10 | Zimmer, Inc. | 444 |
| 11 | Arrow International Inc | 431 |
| 12 | Olympus Corporation of the Americas | 415 |
| 13 | Baxter Healthcare Corporation | 378 |
| 14 | Biomerieux Inc | 369 |
| 15 | Windstone Medical Packaging, Inc. | 336 |
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 39,949 device safety records from 1930 to 2026.