FDA Medical devices recall ·
InSure ONE Fecal Immunochemical Test recall
- Recall number
- Z-0725-2026
- Date
- (initiated September 17, 2025)
- Company / brand
- Enterix, Inc.
236 Fernwood Ave, Edison, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 201,426 test kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.
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.
States: California Florida Georgia Illinois Indiana Kentucky Massachusetts North Carolina New Jersey Nevada New York Ohio Pennsylvania Texas Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0725-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.