Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP,
Summary
The FDA issued a Class II for Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Model by WASATCH PHOTONICS. 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 fail.
Details
Source
Device Recall
External ID
Z-2478-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
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.
Lot/Code Info: all codes included in the model numbers.
Quantity Affected: 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.
Distribution
U.S.
Type: FDA Mandated
Recall Initiated: 2025-08-04
Company
Morrisville, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WASATCH PHOTONICS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WASATCH PHOTONICS have FDA actions?
This is the only FDA action we have on record for WASATCH PHOTONICS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2478-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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