Enterix, Inc. recalls
Every recall we track for Enterix, Inc. — 2 in all, from 2020–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
2 recalls since 2017.
All FDA recall records for Enterix, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Enterix, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Enterix, Inc. recalls
2 shown- Lower riskMedical device
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.
Enterix recalls InSure ONE fecal immunochemical test kits that may produce false negative results when used with Test Card Lot T241102. Affected kits include 10-pack and 25-pack models produced between July 23 and September 12, 2025.
EnterixSep 17, 2025 - Use cautionMedical device
Enterix, Inc. recalls InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from
Enterix, Inc. recalls InSure ONE Test Strips due to potential false positive results. Check lot numbers 770G11 and 770G21 for details.
InSure ONEOct 8, 2020
Enterix, Inc. recall questions
How many recalls has Enterix, Inc. had?
2 recalls from Enterix, Inc. are on record with U.S. safety agencies, from 2020–2025.
What is the most recent Enterix, Inc. recall?
Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010., dated Sep 17, 2025. Every Enterix, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Enterix, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Enterix, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.