BEUDAMED
    FDA Enforcement Class II Ongoing

    EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx

    Recall: Z-0488-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0488-2025
    Event ID
    95461
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Enchroma Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2024
    Initiation Date
    September 6, 2024
    Classification Date
    November 19, 2024
    Address
    2001 Addison St # 335, N/A, Berkeley, CA, 94704-1192, United States

    Description

    EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx

    Reason

    Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.

    Code Info

    Order Numbers: #S166556, #S165570, #S166008, #S166145, #S166935, #S167024, #S168061, #S168409, #S168462, #S169061, #S169266, #S170297, #S170428, #S170496, #S171343, #S172249, #S172993, #S173215, #S173512, #S173548, #S173619, #S173729, #S173920, #S174701, #S174818, #S175254, #S175453, #S175681, #S175744, #S176183, #S176257, #S176715, s175356, s163884, #S163421, #s164055, s164308, s164426, s165796, s164324, s162314, s160669, s160666, s159817, s161084, #s160752, ecp11546,#ECP11807, #ECP11063, ecp11867, ecp10693, s166343, s174985

    Distribution

    Worldwide distribution: US (nationwide): IL, OH, NC, IA, AL, SC, NJ, TX, CO, PA, FL, MI, NY, DU, NM, CA, NH, MT, WV, KY, OR, MA, WI, VA, AZ and OUS (foreign): United Arab Emirates, Japan, and Canada.

    Quantity

    53