Z-2478-2025Class II

Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC...

Name: Z-2478-2025 Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC...
Creator: Wasatch Photonics
Published: 2025-08-04
License: https://open.fda.gov/license/

Wasatch Photonics / initiated 2025-08-04 / Open, Classified / root cause: design

FDA source

WASATCH PHOTONICS began a 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 on 2025-08-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2478-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-04
Posted: 2025-09-11
Recalling firm: Wasatch Photonics
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.
Product code: REM Spectroscopy Instrument
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.
Root cause tag: design
FDA root cause: Radiation Control for Health and Safety Act
Action: Notifications will be sent out to all purchasers of affected models. Notification will include an offer of free RMA (return to factory for repair, then shipment back to customer). All repairs will be performed at the site of original manufacture in Morrisville, NC. Customer notifications to be delivered by 31-Aug-2025.
Quantity in commerce: 192
Distribution: U.S.
Product codes and lots: all codes included in the model numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2478-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2478-2025	Class II	Ongoing	FDA Mandated	2025-09-17	2025-09-11

Product code REM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)