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 18361–18380 of 38,428 recalls
Recalled Item: RUSCH LASERTUBE (Rubber)
The Issue: The firm received reports indicating that the laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH LASERTUBE (Rubber)
The Issue: The firm received reports indicating that the laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH LASERTUBE (Rubber)
The Issue: The firm received reports indicating that the laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH LASERTUBE (Rubber)
The Issue: The firm received reports indicating that the laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers
The Issue: Pin hole package failures compromising sterility of product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Video Laryngoscope
The Issue: A typographical error in the Operations & Maintenance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra
The Issue: Stability did not meet acceptance criteria for visual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief
The Issue: Outflow Graft leaking at the pump connection during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec HeartMate 3 LVAS Implant Kit
The Issue: Outflow Graft leaking at the pump connection during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ally Bone Screw - Product Usage:Bone Screws are indicated for
The Issue: There may be dimensional manufacturing error that represents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prestilix 1600X Prestilix system is a fully integrated remote controlled
The Issue: There has been a reported incident of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prestige II
The Issue: There has been a reported incident of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Silhouette VR This fully integrated system offers intuitive controls with
The Issue: There has been a reported incident of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus XR/a The Proteus XR/a radiographic system offers the flexibility
The Issue: There has been a reported incident of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conformis iTotal Hip Replacement System: HBS-033-00xx-010101
The Issue: Discrepancy of 3mm between the values displayed and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conformis iTotal Hip Replacement System: HBS-033-00xx-020101
The Issue: Discrepancy of 3mm between the values displayed and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precision 500D The Precision 500D R&F X-ray System is intended
The Issue: There has been a reported incident of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Nail Clipper Concave Edge (67710)
The Issue: Compromised seal on the sterile barrier pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Nail Nipper
The Issue: Compromised seal on the sterile barrier pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wombat Living
The Issue: Firm received feedback form the market regarding breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.