Medical device recalls Moderate risk

STANLEY BLACK & DECKER INC. recalls The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FM…

Recall date
November 21, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0681-2020
FDA classification
Class II
Brand / firm
STANLEY BLACK & DECKER INC.
Sold / distributed
Nationwide

Why it was recalled

The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These products would be more appropriately classified into laser Class IIIa (IEC Laser Class IIIR).

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

What was recalled

The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.

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