InSure ONE Fecal Immunochemical Test — Class II medical device recall Z-0725-2026
Ongoing recall by Enterix, Inc., reported 2025-12-10, distributed nationwide. InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative
| Recall number | Z-0725-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Enterix, Inc., Edison, NJ, United States |
| Recall initiated | 2025-09-17 |
| Classified | 2025-11-28 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | PH |
| Quantity | 201,426 test |
| UPC / GTIN / UDI-DI | 00850093003279, 10850093003313, 20850093003310 |
| Lot numbers | TT241102 |
| Model numbers | 90010, 90025, 90030 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0725-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.