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 18221–18240 of 38,428 recalls
Recalled Item: ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i
The Issue: Devices were delivered without the required dry ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee
The Issue: In affected Artis systems the movement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Technopath Multichem S Plus Level 2 - Product Usage: Multichem
The Issue: Devices were delivered without the required dry ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The
The Issue: Devices were delivered without the required dry ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Technopath Multichem S Plus Level 1 - Product Usage: Multichem
The Issue: Devices were delivered without the required dry ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q (material 10848280
The Issue: In affected Artis systems the movement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators
The Issue: Devices were delivered without the required dry ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q (material 10848280
The Issue: In affected Artis systems the movement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus...
The Issue: Devices were delivered without the required dry ice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Zee (material # 10094135
The Issue: In affected Artis systems the movement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 350 Chemistry System
The Issue: negative drift in Creatine Kinase (CK) results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250 Chemistry System
The Issue: negative drift in Creatine Kinase (CK) results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250 Chemistry System
The Issue: negative drift in Creatine Kinase (CK) results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250AT Chemistry System
The Issue: negative drift in Creatine Kinase (CK) results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V-TEK"
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.