Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers — Class II medical device recall Z-2478-2025
Ongoing recall by WASATCH PHOTONICS, reported 2025-09-17. Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser
| Recall number | Z-2478-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | WASATCH PHOTONICS, Morrisville, NC, United States |
| Recall initiated | 2025-08-04 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Quantity | 192 |
| Model numbers | 785-ER-ILC, 785-SR-ILC, 785-SR-ILP, 830-SR-ILC, 830-SR-ILP |
Product
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.
Reason for recall
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
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-2478-2025. 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.