BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-0681-2020 · Reported January 8, 2020

    Enforcement

    Recall Number
    Z-0681-2020
    Event ID
    84499
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    STANLEY BLACK & DECKER INC.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    January 8, 2020
    Initiation Date
    November 21, 2019
    Classification Date
    December 30, 2019
    Address
    400 Executive Blvd, N/A, Southington, CT, 06489-1096, United States

    Description

    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.

    Reason

    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).

    Code Info

    The products involved are DeWALT laser distance measurers, model numbers DWO 165, DWO 1 65S, DW0330S and Stanley Fat Max FMHT77506 TLM 165. These products were produced for DeWALT and Stanley by a contract manufacturer..

    Distribution

    Nationwide

    Quantity

    13917