WASATCH PHOTONICS: Medical Device Recall in 2025 - (Recall #: Z-2478-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: August 4, 2025
Date Posted: September 17, 2025
Recall Number: Z-2478-2025
Event ID: 97520
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.

Status: Ongoing
Product Quantity: 192
Code Information:

all codes included in the model numbers.

Distribution Pattern:

U.S.

Voluntary or Mandated:

FDA Mandated