# FDA recall Z-1946-2024

> **Newport Corp** · Class II · device recall initiated 2024-03-27.

## Product

Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

## Reason for recall

According to 21 CFR 1040.10(f)(4),  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.  However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1946-2024
- **Recalling firm:** Newport Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-27
- **Report date:** 2024-06-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2024

## Citation

> AI Analytics. FDA recall Z-1946-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1946-2024. Source: US FDA. Licensed CC0.

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