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 30161–30180 of 38,428 recalls
Recalled Item: Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle)
The Issue: Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon
The Issue: Devon Light Glove in procedure kits may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon
The Issue: Devon Light Glove in procedure kits may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon
The Issue: Devon Light Glove in procedure kits may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon
The Issue: Devon Light Glove in procedure kits may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon
The Issue: Devon Light Glove in procedure kits may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unilateral external fixation ankle clamp Product Usage: Unilateral external...
The Issue: Ankle clamp was assembled incorrectly; the offset of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Base for Terumo Advanced Perfusion System 1
The Issue: Terumo CVS is implementing field correction activities to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 100/120V AC
The Issue: Terumo CVS is implementing field correction activities to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended
The Issue: Sterility of device maybe compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I-Portal¿ NOTC and VNG
The Issue: complaints of system malfunction and unintended, sudden movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove
The Issue: Kits from Centurion contain a Medtronic/Covidien Light Glove
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyLink Data Management System
The Issue: System Limitations and Software Issues related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac
The Issue: Complaints with the HVAD Abnormal Power Source Switching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeHealth
The Issue: The barometric pressure measurement output of this particular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and
The Issue: Complaints with the HVAD Internal Controller Alarm Battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac
The Issue: Complaints with the HVAD Discolored and Cracked Driveline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD). Catalog #: 1101
The Issue: Complaints with the HVAD Retraction of Pins within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and
The Issue: HeartWare has received complaints relating to damage or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.