# FDA recall Z-0725-2026

> **Enterix, Inc.** · Class II · device recall initiated 2025-09-17.

## 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 for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-0725-2026
- **Recalling firm:** Enterix, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-17
- **Report date:** 2025-12-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Edison, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2026

## Citation

> AI Analytics. FDA recall Z-0725-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0725-2026. Source: US FDA. Licensed CC0.

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