FDA Device recall Z-2478-2025
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 Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of 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 by Wasatch Photonics, citing 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 foun….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2478-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-04 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wasatch Photonics |
| Distribution | n/a |
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
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.
Identifiers
| code_info | all codes included in the model numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2478-2025%22
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