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 13441–13460 of 38,428 recalls
Recalled Item: Flex IUI Set with LED Lighted Speculum and Test kit
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with...
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2 X Sterile Human Home Artificial Insemination Semen Kit (Human)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premium At Home Pro Series Insemination Kit (SKU 644042787927)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: At Home Artificial Intrauterine Insemination Kit (SKU 636391205825
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pro Series Fertility Device (SKU 644042788139)
The Issue: Device was distributed without a proper marketing authorization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) .
The Issue: There is the potential of a bent or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valkyrie LTOWB Collection (P/N 80-820
The Issue: There is the potential of a bent or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) .
The Issue: There is the potential of a bent or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood...
The Issue: There is the potential of a bent or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.