CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report

785/830-SR and 785-Er-ilc Raman Spectrometers, Product recalled

Wasatch Photonics is recalling Wasatch Photonics 785/830-SR and 785-Er-ilc Raman Spectrometers, Product. The recall was initiated on 4 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes included in the model numbers.
Quantity recalled192

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2478-2025
FDA event ID
97520
Recalling firm
Wasatch Photonics, Morrisville, NC
Classification
Class II
Status
Ongoing
Recall initiated
4 Aug 2025
FDA classified
11 Sep 2025
Reported
17 Sep 2025
Type
FDA Mandated
Customers notified by
N/A
Reason category
Device Malfunction

Timeline

4 Aug 2025Recall initiated by company
11 Sep 2025Classified by FDA+38 days
17 Sep 2025Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

U.S.

Questions about this recall

Is 785/830-SR and 785-Er-ilc Raman Spectrometers, Product recalled?

Yes. Wasatch Photonics recalled 785/830-SR and 785-Er-ilc Raman Spectrometers, Product on 4 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2478-2025.

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.

Which lots are affected?

all codes included in the model numbers.

Where was it sold?

U.S.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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