Enterix, Inc.: Device Recall

Recall #Z-0725-2026 · 09/17/2025

Class II: Risk

Recall Details

Recall Number: Z-0725-2026
Classification: Class II
Product Type: Device
Recalling Firm: Enterix, Inc.
Status: Ongoing
Date Initiated: 09/17/2025
Location: Edison, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 201,426 test kits

Reason for Recall

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Product Description

InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.