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 35221–35240 of 38,428 recalls
Recalled Item: Baxter
The Issue: the white printed paper layer on the pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain AG. For use in the screening and detection of cervical cancer.
The Issue: PrepStain system rack setting was incorrectly entered on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain Tecan US-II. For use in the screening and detection
The Issue: PrepStain system rack setting was incorrectly entered on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain Tecan US-I. For use in the screening and detection
The Issue: PrepStain system rack setting was incorrectly entered on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 1) Asnis III Cannulated Screw 4.0x40mm TL
The Issue: Stryker received a report that the length of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT
The Issue: The products were produced using the wrong color
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Suction Wand Model S099B
The Issue: Sorin Group is recalling certain lots of Edwards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Mullins Transseptal Adult 7F
The Issue: Medtronic identified a specific labeling issue for specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions:
The Issue: IntelliVue Smart-hopping 1.4 GHz Access Point may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: pCO2 D788 Membranes. Distributed by Radiometer America
The Issue: RADIOMETER has become aware that some D788 pCO2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 6
The Issue: The patient support may move in an unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Reservoirs
The Issue: Medtronic is recalling certain lots of Medtronic MiniMed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safety Lancets - Odyssey
The Issue: Lancets were not sterilized within the dose range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL
The Issue: Certain lots of these Bur Hole Probe Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER
The Issue: Certain lots of these Bur Hole Probe Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL
The Issue: Certain lots of these Bur Hole Probe Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER
The Issue: Certain lots of these Bur Hole Probe Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL
The Issue: Certain lots of these Bur Hole Probe Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL
The Issue: Certain lots of these Bur Hole Probe Covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System Radiation treatment planning
The Issue: Upgrade installation script is designed to overwrite the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.