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 23721–23740 of 38,428 recalls
Recalled Item: VITROS Chemistry Products PHYT Slides
The Issue: The firm identified the potential for biased results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INVUITY(R) PhotonBlade(TM)
The Issue: A small number of customer observations were recently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and...
The Issue: Arrow is recalling additional lots that were identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module model 8100
The Issue: There is a potential risk that could cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
The Issue: Arrow is recalling additional lots that were identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC Unit
The Issue: BD initiated the recall of Alaris PC unit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900
The Issue: This recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tosoh¿Sorter 9tray
The Issue: This recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kelyniam Custom Skull Implant (CSI)
The Issue: Significant design changes made to the Custom Skull
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kelyniam Custom Skull Implant (CSI)
The Issue: Significant design changes made to the Custom Skull
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kelyniam Custom Skull Implant (CSI)
The Issue: Significant design changes made to the Custom Skull
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kelyniam Custom Skull Implant (CSI)
The Issue: Significant design changes made to the Custom Skull
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Group Aortic Arch Cannula
The Issue: Identification of excess plastic on the tip of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penumbra 3D Revascularization Device It is indicated for used in
The Issue: Penumbra has identified an issue in these four
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nicolet¿ Elite¿ 3 MHz OB Probe
The Issue: Some of the Elite 2 and 3 Obstetric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nicolet¿ Elite¿ 2 MHz OB Probe
The Issue: Some of the Elite 2 and 3 Obstetric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nicolet¿ Elite¿ 5 MHz Vascular Probe
The Issue: Some of the Elite 2 and 3 Obstetric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe
The Issue: Some of the Elite 2 and 3 Obstetric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Connect Diabetes Management App
The Issue: Certain iOS and Android App versions contain a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Connect diabetes management software app
The Issue: Certain iOS and Android App versions contain a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.