Lago X — Class II medical device recall Z-1941-2025
Ongoing recall by Spectral Instruments Inc, reported 2025-06-25. The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exa
| Recall number | Z-1941-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Spectral Instruments Inc, Tucson, AZ, United States |
| Recall initiated | 2025-05-13 |
| Classified | 2025-06-18 |
| Reported by FDA | 2025-06-25 |
| Quantity | 39 |
| Reason classes | labeling |
Product
Lago X
Reason for recall
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
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-1941-2025. 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.