WASATCH PHOTONICS: Device Recall
Recall #Z-2478-2025 · 08/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2478-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- WASATCH PHOTONICS
- Status
- Ongoing
- Date Initiated
- 08/04/2025
- Location
- Morrisville, NC, United States
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 192
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.
Product Description
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.
Distribution Pattern
U.S.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.