Enterix Recalls

1 recall found for Enterix. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Enterix Recalls InSure ONE Test Kits Due to False Negative Risk

Enterix recalled 201,426 InSure ONE fecal immunochemical test kits on September 17, 2025. The kits may produce false negative results due to failed sensitivity testing with Test Card Lot T241102. The recall affects units distributed worldwide, including multiple states in the U.S.

Enterix
InSure ONE
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Total Recalls
1
Pages
1