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 8461–8480 of 38,428 recalls
Recalled Item: DuraLife Autoclavable Silicone Extension Tube
The Issue: DuraLife devices instructions for cleaning and sterilization have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513
The Issue: Beckman Coulter has become aware of an intermittent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuraLife Autoclavable Silicone Extension Tube
The Issue: DuraLife devices instructions for cleaning and sterilization have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Bicarbonate
The Issue: There is a potential for a decrease in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES (Med ES Main)
The Issue: Automated dispensing cabinet software is experiencing: 1) ES
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Infinity M300 and M300+
The Issue: The software on the Infinity CentralStation drops peaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Infinity CentralStation (ICS)
The Issue: The software on the Infinity CentralStation drops peaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump
The Issue: The power cord supplied (Type J plug end)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO Instrument Kit for EPS Plate
The Issue: Instrument Kits for EPS plates may contain drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProSun International Luxura Vegaz
The Issue: In some cases the communication isolator installed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pilot COVID-19 At-Home Test
The Issue: The liquid buffer component in the affected test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViziShot 2 Single Use Aspiration Needle
The Issue: Product non-conformance pertaining to the angle of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: To be used with ultrasound endoscopes for ultrasound guided fine
The Issue: Product non-conformance pertaining to the angle of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA
The Issue: Some of the tubes may be incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM)
The Issue: Suture breakage during intra-operative use could result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom pro+ mattress
The Issue: There is a potential for mattress cover damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eye and Ear Dropper
The Issue: for glass dropper to have glass particulate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicine Dropper
The Issue: for glass dropper to have glass particulate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: binx io CT/NG Assay- Single-use Cartridge for the qualitative detection
The Issue: May not meet the declared performance characteristics for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distal Phasitron
The Issue: Breathing circuit reservoir bag may be assembled at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.