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 4601–4620 of 38,428 recalls
Recalled Item: DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit
The Issue: The "DVOT brand" rapid test kits have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DVOT SARS-CoV-2 ANTIGEN TEST KIT
The Issue: The "DVOT brand" rapid test kits have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit
The Issue: The "DVOT brand" rapid test kits have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insyte Autoguard BC
The Issue: Catheters may contain a hole in the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS is a family of dedicated angiography systems developed for
The Issue: A potential issue with ARTIS icono systems equipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS is a family of dedicated angiography systems developed for
The Issue: A potential issue with ARTIS icono systems equipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS is a family of dedicated angiography systems developed for
The Issue: A potential issue with ARTIS icono systems equipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch
The Issue: The tube may fall into the surgical site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multiple Digital Analog Products labeled as: NobelBiocare...
The Issue: Due to a manufacturing issue, the product has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate 3 System Controllers provided within the following HeartMate 3
The Issue: Left ventricular assist system controller UI membrane/screen may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow
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-6FH
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-4HH-1FH-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 MINI CR-2HH-1FH-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-1FH-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: BD PYXIS MEDBANK TWR MN CR-8HH-3FH-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-12HH-1FH
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-12HH-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-1FH-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-10HH-2FM-P
The Issue: Due to software issue, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.