Labeled in part: I Color Complete / Color Lens — Class II medical device recall Z-0950-2015
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 number | Z-0950-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intertrade Imports Inc., Jacksonville, FL, United States |
| Recall initiated | 2014-09-10 |
| Classified | 2015-01-12 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2019-10-07 |
| Distributed | CA, FL, TX |
| Countries outside the US | BB |
| Quantity | 750 units |
| Reason classes | unapproved product |
| Pathogens | bacillus cereus |
Product
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens 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. 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-0950-2015. 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.