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 14141–14160 of 38,428 recalls
Recalled Item: Kit Model #650305414
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #65193091
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and
The Issue: The device may detect an incorrect Heater Bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS Software Versions 5.1 and higher
The Issue: There is a potential for the wrong patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streamline MIS Navigation System Taps
The Issue: The Streamline MIS Navigation System taps are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bien-Air Surgery SN ******* MULTIFUNCTION PEDAL OSSEODUO -
The Issue: The magnet located inside the foot pedal may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bien-Air Surgery SN ******* OSSEOSTAP Footcontrol - Product
The Issue: The magnet located inside the foot pedal may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS Software Version 5.6.1 - Product Usage: intended for
The Issue: FUJIFILM has become aware of the possibility that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bien-Air Surgery SN **** FOOTCTRL OSSEODOC - Product
The Issue: The magnet located inside the foot pedal may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Entellus Medical SN ******* Shaver System Foot Pedal
The Issue: The magnet located inside the foot pedal may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Instruments SN ******* S2 MINI FOOT Pedal
The Issue: The magnet located inside the foot pedal may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate
The Issue: VGDF (VGA) Faceplate failure results in failure of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
The Issue: Insulin pumps may display unexpected fluctuation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions For Use document of the GPS Trackers.
The Issue: Appropriateness of the language used in the Tracker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uroskop Omnia
The Issue: After the March 2019 corrective action on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uroskop Omnia Max
The Issue: After the March 2019 corrective action on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6
The Issue: Product in the foil package for VICRYL V960
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
The Issue: When the delivery catheter was attempted to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
The Issue: Due to secondary deployment fiber being attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.