# FDA recall Z-2976-2024

> **PACIFIC LASERTECH, LLC** · Class II · device recall initiated 2024-03-01.

## Product

25-LHP-928, HeNe Laser System, 25 mW

## Reason for recall

These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires,  Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2976-2024
- **Recalling firm:** PACIFIC LASERTECH, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-01
- **Report date:** 2024-09-18

- **Voluntary/Mandated:** FDA Mandated
- **Location:** San Marcos, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2976-2024

## Citation

> AI Analytics. FDA recall Z-2976-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2976-2024. Source: US FDA. Licensed CC0.

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