Official recall record
25-LHP-828, HeNe Laser System, 35 mW
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-03-01
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- PACIFIC LASERTECH, LLC
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-03-01 · US FDA — Medical Devices
25-LHP-928, HeNe Laser System, 25 mW - 2024-03-01 · US FDA — Medical Devices
N-LHP-928, HeNe Laser System, 35 mW
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