Enterix recalls
Enterix has 2 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 10 Dec 2025. 1 is still ongoing. 1 was reported in the last 12 months.
Total recalls2since 2020
Last 12 months1reported
Class I00% of total
Ongoing1latest 10 Dec 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why enterix is recalled
Product types
By year
Ongoing enterix recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | InSure ONE Fecal Immunochemical Test recalled by Enterix | Enterix | Other | Nationwide |
All enterix recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | InSure ONE Fecal Immunochemical Test recalled by Enterix | Enterix | Other | Nationwide |
| Device | CLASS II | InSure ONE Test Strips vials-fecal immunochemical test recalled | Enterix | Lead & Heavy Metals | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.