FDA recall Z-0488-2025

Enchroma Inc · Class II · device

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

Reason for recall

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.

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.

Key facts

Status
Ongoing
Initiation date
2024-09-06
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Berkeley, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2025