Gut Microbiome Test XL — Class II medical device recall Z-0782-2026
Ongoing recall by GET TESTED INTERNATIONAL AB, reported 2025-12-10, distributed nationwide. Distribution without premarket approval/clearance.
| Recall number | Z-0782-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GET TESTED INTERNATIONAL AB, Vastervik, Sweden |
| Recall initiated | 2025-11-03 |
| Classified | 2025-12-01 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00616612785909 |
Product
Gut Microbiome Test XL
Reason for recall
Distribution without premarket approval/clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0782-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.