Device recall
Z-0725-2026: InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL…
FDA device recall · Class II · Enterix, Inc.
Key facts
| Recall number (Z-number) | Z-0725-2026 |
|---|---|
| Recall event | 97802 |
| Product | 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. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively… |
| Product code | KHE |
| Recalling firm | Enterix, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170548 |
| FEI number | 3003224146 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database