FDA Medical devices recall ·
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers… recall
- Recall number
- Z-2478-2025
- Date
- (initiated August 4, 2025)
- Company / brand
- Wasatch Photonics
808 Aviation Pkwy Ste 1400, Morrisville, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 192
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
all codes included in the model numbers.
Distribution
U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2478-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.