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 14761–14780 of 38,428 recalls
Recalled Item: TTDEYE (brand) Radial Pink
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re
The Issue: The label on the cardbox and the blister
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TTDEYE (brand) Radial Brown
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TTDEYE (brand) Black Starshine
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TTDEYE (brand) Devil Red
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TTDEYE (brand) Diamonds Starlight
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TTDEYE (brand) Flower Grey
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TTDEYE (brand) Flower Brown
The Issue: Colored contact lenses were distributed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250 Proton Radiation Treatment System
The Issue: The perforated screen that divides the inside of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software versions syngo.CT VB20 or VB20_SP1 in the following systems:
The Issue: Sporadic problems with the current software may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARTO 3 System (Software Version V7.1.80)
The Issue: Software defect may result in disapperance of tag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE ONE
The Issue: CARESCAPE ONE may not provide visual and audible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray System
The Issue: The metal edge overlap of the mylar strip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray System
The Issue: The metal edge overlap of the mylar strip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray System
The Issue: The metal edge overlap of the mylar strip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Partial Knee Peg Drill
The Issue: There have been issues experienced with the peg
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Partial Knee Peg Drill Guide
The Issue: There have been issues experienced with the peg
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClosureFast Micro Introducer Sheath Set
The Issue: Sterile introducer sheath set manufactured under one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity ci series System Control Module (SCM)
The Issue: Quality Control results were not properly evaluated for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.