RegWardenFDA facility compliance records
Company

VOLK OPTICAL INC.

4 recall(s) on record — most severe on record: Class III.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2015: 2 recalls; 2016: 1 recalls1’12’13’142’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IIITerminated2016-02-02
    The firm discovered that the incorrect lot number was engraved on the product.
  • Class IIITerminated2015-02-27
    Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
  • Class IIITerminated2015-02-27
    Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
  • Class IIITerminated2012-10-25
    The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “VOLK OPTICAL INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9000705-volk-optical-inc/

Not open yet

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.

Planned

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.