Medical device recalls Moderate risk

Ii - Vi product recalled over fire hazard

Recall date
December 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ii - Vi Incorporated recalls 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Recall number
Z-1614-2018
FDA classification
Class II
Brand / firm
Ii - Vi Incorporated
Sold / distributed
US Distribution to Oregon.

Why it was recalled

Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.

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

What was recalled

11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

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