Enterix, Inc.
Enterix, Inc. appears in FDA public data with 2 recalls, 3 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0725-2026, Class II) was initiated on September 17, 2025. Its most recent 510(k) clearance was granted on October 5, 2017.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0725-2026 | Class II | InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack | September 17, 2025 |
| Z-0590-2021 | Class II | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human | October 8, 2020 |