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 6141–6160 of 38,428 recalls
Recalled Item: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy
The Issue: Kits should contain Filter Straws with Standard Luer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueDent Clear
The Issue: Customers unable to use cartridges due to formatting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueDent Yellow
The Issue: Customers unable to use cartridges due to formatting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueDent Cyan
The Issue: Customers unable to use cartridges due to formatting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueDent Magenta
The Issue: Customers unable to use cartridges due to formatting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueDent White
The Issue: Customers unable to use cartridges due to formatting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INS5HND / Integra Cranial access kit (without Prep
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : HITHSP04 / Integra Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INS7260 / Integra¿ Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INS7270 / Integra¿ Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INS7250 / Integra Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : 31156 / COMBO KIT CONTAINS INS-8301
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INS7280 / Integra¿ Cranial Access Kit. For access to the
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INSHITHND / Integra¿ Cranial access kit (without Prep
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : HITHSP06 / Integra Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INSHITH / Integra¿ Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: : INSHITHRZN / Integra Cranial Access Kit. For access
The Issue: A defect in the sterile packaging (header bag)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE VIABIL Short Wire Biliary Endoprosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System
The Issue: The kit contains a flange that has a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InstaClear Lens Cleaner-indicated for use during routine diagnostic...
The Issue: Japanese IFU version had slightly different language and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.