25-LHP-828 — Class II medical device recall Z-2975-2024
Ongoing recall by PACIFIC LASERTECH, LLC, reported 2024-09-18, distributed nationwide. These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system cl
| Recall number | Z-2975-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | PACIFIC LASERTECH, LLC, San Marcos, CA, United States |
| Recall initiated | 2024-03-01 |
| Classified | 2024-09-10 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
Product
25-LHP-828, HeNe Laser System, 35 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2975-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.