11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sig...

FDA Recall #Z-1614-2018 — Class II — December 13, 2017

Recall #Z-1614-2018 Date: December 13, 2017 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Ii - Vi Incorporated — Saxonburg, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

323,972

Distribution

US Distribution to Oregon.

Code Information

Model Numbers: 25-0655 & 25-0657

Status

Terminated

Voluntary / Mandated

FDA Mandated