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 6921–6940 of 38,428 recalls
Recalled Item: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
The Issue: There is a risk of endobronchial combustion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiohelp-i
The Issue: It was found that the fixation (weld) employed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
The Issue: There is a risk of endobronchial combustion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150
The Issue: There is a risk of endobronchial combustion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180
The Issue: There is a risk of endobronchial combustion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190
The Issue: There is a risk of endobronchial combustion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
The Issue: There is a risk of endobronchial combustion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Radiology Solutions
The Issue: Change Healthcare has identified a software issue where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal...
The Issue: May have increased water path restriction within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life
The Issue: May have increased water path restriction within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RANDOX Total Bilirubin.
The Issue: Randox has had reports of elevated patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariSoft infusion set
The Issue: The Varisoft infusion set is used in conjunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline manual resuscitators with integrated manometer
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD gravity sets (Product Name
The Issue: Affected infusion sets labeled as free of DEHP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Extension Sets (Product Name
The Issue: Affected infusion sets labeled as free of DEHP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.