Enterix, Inc.
Edison, NJ
This page shows every FDA and USDA recall linked to Enterix, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
3
Total Recalls
2008
First Recall
2025
Most Recent
InSure ONE Fecal Immunochemical Test. Labeled as follows:
1. Insure ONE POL Patient Kit - 10 pack. Model Numb...
Nov 28, 2025
· Device
Active
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin...
Oct 8, 2020
· Device
Terminated
INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit)...
Dec 29, 2008
· Device
Terminated