HIGH

Wasatch Photonics Recalls Raman Spectrometers Due to Laser Risks

Wasatch Photonics recalled 192 Raman spectrometers on August 4, 2025. Two potential laser safety failure modes could pose serious risks. No incidents have been reported, but excessive force or vibration may trigger failures.

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact WASATCH PHOTONICS or your healthcare provider for instructions. Notification method: N/A

Product Details

The recall involves Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers. Affected models include 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC, and 785-ER-ILC. These devices were distributed in the U.S.

The Hazard

The recall addresses two potential laser safety failure modes. These include overcurrent of the laser diode and a fail-unsafe mode that could occur under excessive force or extreme vibration.

Reported Incidents

No incidents or injuries have been reported related to these models. The manufacturer has not found these failure modes occurring in the field or factory.

What to Do

Stop using the devices immediately. Follow the recall instructions provided by the manufacturer and contact Wasatch Photonics or your healthcare provider for further guidance.

Contact Information

For more information, contact Wasatch Photonics at their official website or through their customer service hotline. Visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2478-2025 for details.

Key Facts

  • 192 units recalled
  • Models include 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC, 785-ER-ILC
  • Potential laser safety hazards identified
  • No reported incidents or injuries
  • Immediate stop-use recommended
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
785-SR-ILP
785-SR-ILC
830-SR-ILP
830-SR-ILC
785-ER-ILC
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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