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 3321–3340 of 38,428 recalls
Recalled Item: Tec 850 SEV Anesthesia Vaporizer
The Issue: Due to a manufacturing issue, certain Tec 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnVisio Patient Pad Transition Cushion
The Issue: There is a potential safety risk caused by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tec 6 Plus Anesthesia Vaporizer
The Issue: Due to a manufacturing issue, certain Tec 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tec 850 ISO Anesthesia Vaporizer
The Issue: Due to a manufacturing issue, certain Tec 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tec 820 SEV Anesthesia Vaporizer
The Issue: Due to a manufacturing issue, certain Tec 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access hsTnI Reagent
The Issue: Beckman Coulter, Inc. is recalling their Access hsTnI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI mBrace
The Issue: Complaint defects have been noted regarding the adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI mBrace
The Issue: Complaint defects have been noted regarding the adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI mBrace
The Issue: Complaint defects have been noted regarding the adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI mBrace
The Issue: Complaint defects have been noted regarding the adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT and Spectral CT Plus. Model Numbers: 728333
The Issue: for a plan box not updated issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number:
The Issue: The warming surfaces or incubator well temperatures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:
The Issue: The warming surfaces or incubator well temperatures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: mint Lesion
The Issue: Some software versions have a malfunction where they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: mint Lesion
The Issue: Some software versions have a malfunction where they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Systems Product Name: Multiple/unknown Model/Catalog Number:...
The Issue: The warming surfaces or incubator well temperatures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog
The Issue: The warming surfaces or incubator well temperatures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:
The Issue: The warming surfaces or incubator well temperatures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012
The Issue: The warming surfaces or incubator well temperatures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011....
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.