Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser… — Class II medical device recall Z-2068-2015
Terminated recall by Nidek Inc, reported 2015-07-22, distributed in CA, IL, MA, MN, MO, NE, NJ, NY…. Accessories to the GYC-1000 laser were missing Laser Aperture labels.
| Recall number | Z-2068-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2015-03-25 |
| Classified | 2015-07-14 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2015-07-14 |
| Distributed | CA, IL, MA, MN, MO, NE, NJ, NY, OR, RI, TX, UT, WA, WI |
| Reason classes | labeling |
| Model numbers | 0W02, 0Z20, 1000, GYC4EP-01, GYC4EP-1 |
Product
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Reason for recall
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
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-2068-2015. 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.