FDA Medical devices recall ·
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1… recall
- Recall number
- Z-0488-2025
- Date
- (initiated September 6, 2024)
- Company / brand
- Enchroma Inc
2001 Addison St # 335, Berkeley, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 53
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alabama Arizona California Colorado Florida Iowa Illinois Kentucky Massachusetts Michigan Montana North Carolina New Hampshire New Jersey New Mexico New York Ohio Oregon Pennsylvania South Carolina Texas Virginia Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0488-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.