Medical Device Recalls
Search 39,794 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 |
|---|---|---|---|---|
| Jul 17, 2026 | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number ... | Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria... | Class II | Remel Europe Ltd. |
| Jul 16, 2026 | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 7220... | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degr... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 16, 2026 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxoli... | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently con... | Class II | Straumann USA LLC |
| Jul 16, 2026 | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 7222... | Two software related issues: 1) Potential image quality degradation that may lead to delay of t... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 16, 2026 | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)008514580051... | Firm has identified mismatches between the outbreak strain and the reference strain used in the d... | Class II | Biofire Defense |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, 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 | 632 |
| 5 | Siemens Medical Solutions USA, Inc | 623 |
| 6 | ICU Medical, Inc. | 596 |
| 7 | Medline Industries, LP | 484 |
| 8 | GE Healthcare, LLC | 474 |
| 9 | Siemens Healthcare Diagnostics, Inc. | 459 |
| 10 | Zimmer, Inc. | 444 |
| 11 | Arrow International Inc | 431 |
| 12 | Olympus Corporation of the Americas | 414 |
| 13 | Baxter Healthcare Corporation | 376 |
| 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 39,794 device safety records from 1930 to 2026.