FDAMarch 1, 2024device

25-LHP-828, HeNe Laser System, 35 mW

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

FDA enforcement status: Ongoing

Brands named

pacific lasertechpacific

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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25-LHP-828, HeNe Laser System, 35 mW — Recall Details · AllClear