Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6 — Class III medical device recall Z-1685-2015
Terminated recall by Volk Optical Inc, reported 2015-06-03, distributed in MA, VA. Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
| Recall number | Z-1685-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volk Optical Inc, Mentor, OH, United States |
| Recall initiated | 2015-02-27 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2016-02-19 |
| Distributed | MA, VA |
| Countries outside the US | MX, SE |
| Quantity | 6 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00811608010106 |
| Lot numbers | BE09243 |
| Model numbers | V25LC |
Product
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Reason for recall
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
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-1685-2015. 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.