Z-0488-2025Class II

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx...

Name: Z-0488-2025 EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx...
Creator: Enchroma Inc
Published: 2024-09-06
License: https://open.fda.gov/license/

Enchroma Inc / initiated 2024-09-06 / Open, Classified / root cause: design

FDA source

Enchroma Inc began a recall of 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... on 2024-09-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0488-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-06
Posted: 2024-11-19
Recalling firm: Enchroma Inc
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
Product code: NAI Lens, Prescription, Color Deficiency
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 9/6/24, recall notices were emailed to customers who were asked to do the following: 1) Return affected devices. 2) immediately cease use of the devices, package and return the devices to their practice. 2) Complete and return the response form via email to [email protected] The firm will provide a full refund of to the establishment upon receipt of the returned devices as well as any extended warranty that may be associated with the devices. Customers with additional questions can contact the firm at [email protected]
Quantity in commerce: 53
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-19

Product code NAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)