Medical device recalls Moderate risk

WASATCH PHOTONICS recalls Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 83…

Recall date
August 4, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2478-2025
FDA classification
Class II
Brand / firm
WASATCH PHOTONICS
Sold / distributed
U.S.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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