Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 28521–28540 of 38,428 recalls
Recalled Item: STD KIT GK213
The Issue: Applied Medical Resources Corporation is recalling CA500 Epix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STD GK258
The Issue: Applied Medical Resources Corporation is recalling CA500 Epix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CA500 Epix Universal Clip Applier Product Usage: The Epix disposable
The Issue: Applied Medical Resources Corporation is recalling CA500 Epix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo Plaza Picture archiving and communication system. Software only. PACS
The Issue: Siemens is releasing an updated software version to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Symbiq infusion pump is a device used in a
The Issue: for the Symbiq pole clamp assemblies to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLIS Microplate System
The Issue: The error "Washer Reagent Clean Fluid" level low
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number:...
The Issue: Drager became aware of situations where the error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus
The Issue: Drager became aware of situations where the error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
The Issue: Manufacturing of the joint between the inner catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InterGuard 5.5mm Econo
The Issue: Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hip Preservation System Signature Series PreBent Burs under the following
The Issue: Metal shavings released from burs during use are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Concerto Basic Shower Trolley is intended for assisted hygiene care
The Issue: Reports of the bolts connecting the stretcher to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000
The Issue: Product marketed without a 510 (k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000
The Issue: Product marketed without a 510 (k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog
The Issue: The Mallinckrodt (Therakos) post-market monitoring process detected an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Chemistry System
The Issue: Increased U90-382 or 6LU condition codes generated by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Increased U90-382 or 6LU condition codes generated by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 350 Chemistry System
The Issue: Increased U90-382 or 6LU condition codes generated by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250 Chemistry Systems
The Issue: Increased U90-382 or 6LU condition codes generated by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System
The Issue: Increased U90-382 or 6LU condition codes generated by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.