Edison, NJ, United States
Enterix, Inc. recalls
2 recalls recorded since 2018, most recently on 17 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 September 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0725-2026
- 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.
Terminated Class II Medical devices
- Recall started
- 8 October 2020
- Terminated
- 10 January 2023
- Reason
- Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy
- Distribution
- Worldwide distribution - US Nationwide and the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0590-2021
- InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.