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 13941–13960 of 38,428 recalls
Recalled Item: Cardioblate CryoFlex
The Issue: There is a potential defect in the seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardioblate CryoFlex
The Issue: There is a potential defect in the seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardioblate CryoFlex
The Issue: There is a potential defect in the seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminesse ML PMMA
The Issue: Heat-cured polymethylmethacrylate (PMMA) milling blank product used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
The Issue: The product did not receive pre-market approval or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas infinity central lab/cobas infinity core license-The cobas infinity IT
The Issue: Incorrect Validation of Results Due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
The Issue: The incorrect lot number was printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT)
The Issue: Product does not meet internal testing criterion; use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAS-930A Flat Panel Monitor (FPD) used in conjunction with the
The Issue: There is a potential that the cable of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation standalone software treatment planning system
The Issue: If a region of interest (ROI) or point
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic
The Issue: Tightening the LIGAPASS Band with this instrument, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog 02145P
The Issue: Strain should be VIM-1 positive but is confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Each KWIK-STIK unit contains a lyophilized microorganism pellet
The Issue: KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Each KWIK-STIK unit contains a lyophilized microorganism pellet
The Issue: KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Each KWIK-STIK unit contains a lyophilized microorganism pellet
The Issue: QC Sets and Panels: KWIK-STIK 2 Pack (Catalog#
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning
The Issue: for cleaning solution intrusion into endoscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used
The Issue: Risk of Sling Clip breakage while in use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog 314-13-23
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog 314-13-33
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Strep B Carrot Broth One-Step
The Issue: Streptococcus culture medium contains an incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.