Data Foundry

Medical device recalls 2015

Labeled in part: I Color Complete / Crazy Lens — Class II medical device recall Z-0951-2015

Terminated recall by Intertrade Imports Inc., reported 2015-01-21, distributed in CA, FL, TX. A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the co

Recall numberZ-0951-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntertrade Imports Inc., Jacksonville, FL, United States
Recall initiated2014-09-10
Classified2015-01-12
Reported by FDA2015-01-21
Terminated2019-10-07
DistributedCA, FL, TX
Countries outside the USBB
Quantity2,850 units
Reason classessterility, unapproved product
Pathogensbacillus cereus
Model numbers032, 050, 073

Product

Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) Product Usage - Eye contact lens

Reason for recall

A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. I Color Color Complete brand color contact lenses are unapproved medical devices.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0951-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.