Class III — Volk Optical Inc
| Recalling firm | VOLK OPTICAL INC. |
|---|---|
| Registered facility | VOLK OPTICAL INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. |
| 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. |
| Quantity | 6 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden. |
| Initiated | 2015-02-27 |
| Classified | 2015-05-28 |
| Terminated | 2016-02-19 |
| Recall number | Z-1685-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Volk Optical Inc (Z-1685-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71014/
Alerts for VOLK OPTICAL INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.