Enterix Recalls
2 recalls on record · December 23, 2020 to December 10, 2025 · Medical Devices
Recalls by year
20
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 10, 2025Medical DevicesFDA
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001
Hazard: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
December 23, 2020Medical DevicesFDA
Enterix, Inc. recalls InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from bloo
Hazard: 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