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 11101–11120 of 38,428 recalls
Recalled Item: Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
The Issue: product mix where the size and/or offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
The Issue: product mix where the size and/or offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1)Traverse Rail Carrier E-System
The Issue: Traverse rail carriage delivered with non-conforming screws are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1688 Camera Control Unit (CCU)
The Issue: A software defect in the camera control unit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIRRUS HD-OCT
The Issue: Optic nerve head angiography scan to be turned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BUTLER Clear Dip
The Issue: Product lacks premarket clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Everest MI XT Inner Dilator
The Issue: Stryker received two (2) complaints for units from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartSine Samaritan PAD
The Issue: Semi-automatic defibrillators shipped out by Stryker without battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For
The Issue: COVID-19 test kits (Antibody Rapid Test kit and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone
The Issue: During insertion of the middle phalanx implant into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone...
The Issue: During insertion of the middle phalanx implant into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all
The Issue: COVID-19 test kits (Antibody Rapid Test kit and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and
The Issue: COVID-19 test kits (Antibody Rapid Test kit and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Everest MI XT Outer Dilator
The Issue: Stryker received two (2) complaints for units from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARA (Computer Assisted Retinal Analysis)
The Issue: Retinal analysis system software has some features, based
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 Fr. X 65 cm Arrow-Trerotola PTD Kit
The Issue: The firm received reports indicating PTD tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.