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 4621–4640 of 38,428 recalls
Recalled Item: BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-2HH-6FM
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT...
The Issue: Any single affected ventilator should only be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK MINI CR-4HH-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-14HH-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with
The Issue: for false negative response on the NIM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESG-410 Electrosurgical Generator- In conjunction with electrosurgical...
The Issue: Electrosurgical Generators ESG-410 does not power on upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cepheid
The Issue: Specimen collection device may leak after the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
The Issue: for defective test cartridges which may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Call Station
The Issue: There is a risk that alarms will not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Call Station
The Issue: This is a risk that alarms will not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFIRE Blood Culture Identification 2 (BCID2) Panel
The Issue: If blood culture identification panel is used in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.