Recall Z-0725-2026— Enterix, Inc.

Name: FDA recall Z-0725-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Class II · Ongoing

Class II FDA medical device recall by Enterix, Inc., initiated 2025-09-17. It names one FDA 510(k) clearance: K170548. Product: 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.. Reason: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results..

Recalling firm: Enterix, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-17
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K170548 — InSure ONEEnterix, Inc.·cleared 2017-10-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.