Medical device recalls Moderate risk

Flux Technology Inc. recalls Lazervida 10W diode laser cutter and engraver with Lazervida shield.

Recall date
February 19, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1878-2025
FDA classification
Class II
Brand / firm
Flux Technology Inc.
Sold / distributed
US

Why it was recalled

Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lazervida 10W diode laser cutter and engraver with Lazervida shield.

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