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Open, Classified

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.

FDA Recall Z-2478-2025 · Posted 2025-09-11

Recalling FirmWASATCH PHOTONICS
Recall StatusOpen, Classified
Product CodeREM
Date Initiated2025-08-04
Product Quantity192

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.

Firm Action

Notifications will be sent out to all purchasers of affected models. Notification will include an offer of free RMA (return to factory for repair, then shipment back to customer). All repairs will be performed at the site of original manufacture in Morrisville, NC. Customer notifications to be delivered by 31-Aug-2025.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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