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 36701–36720 of 38,428 recalls
Recalled Item: Praxair Vantage Grab n Go - Gas Cylinder pressure regulator
The Issue: Isolated incidents of ignition inside Grab n' Go
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek 11 MM Fully Fluted Reamer
The Issue: Specific units of the DePuy Mitek Sterile Reamers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Centricity PACS Workstation
The Issue: While merging exams in a test instance, merges
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viterion TeleHealth Monitor Model Number V100-BGM
The Issue: Viterion telehealth monitors do not transmit "HI" (above
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viterion TeleHealth Monitor Model Number V100
The Issue: Viterion telehealth monitors do not transmit "HI" (above
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viterion TeleHealth Monitor Model Number V500
The Issue: Viterion telehealth monitors do not transmit "HI" (above
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConMed Linvatec Biomaterials
The Issue: ConMed Linvatech recalled one lot of their PopLok
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch and Lomb 27G sterile cannula packed in the Bausch
The Issue: Some disposable cannulas (with 4-digit lot numbers) provided
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EEG NeuroAmp
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Offset Tibial Tray 2.5 mm Adaptor
The Issue: Biomet investigation identified that the square end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook ES pump is intended for use with B. Braun
The Issue: This notice is being provided in follow up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba TSX-30IC AQUlLlON ONE System
The Issue: Due to a problem with the control software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona The Personalized Knee System
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona The Personalized Knee System
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona The Personalized Knee System
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona
The Issue: All lots of the Persona Cemented Tibial Drill,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100
The Issue: Operating range of the ADVIA Centaur systems is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.