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 9021–9040 of 38,428 recalls
Recalled Item: CADD Administration Set
The Issue: There are two potential issues with CADD Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m System. The Alinity m System is designed to
The Issue: The firm identified the following three potential issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos Agile Max
The Issue: There is potential for the footrest to detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Luminos TF
The Issue: There is potential for the footrest to detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Luminos Agile
The Issue: There is potential for the footrest to detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal
The Issue: for pilot balloon non-inflation or cuff non-deflation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Slick Set Cuffed Endotracheal Tube and Stylet Set
The Issue: for pilot balloon non-inflation or cuff non-deflation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal
The Issue: for pilot balloon non-inflation or cuff non-deflation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadiaLux Lighted Retractor (Pink)
The Issue: Defect in sterile pouch seal, incomplete seal, of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Detect Covid-19 Test Product/Model Number: 21205
The Issue: There is an increased chance that the tests
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: MEDLINE PREP TRAY
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: MEDLINE CABG PACK
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: MEDLINE PAIN TRAY
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY
The Issue: The recall is due to the perforated bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.