Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6 Recalled by Volk Optical Inc Due to Mislabeling

Date: February 27, 2015
Company: Volk Optical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Volk Optical Inc directly.

Affected Products

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

Why Was This Recalled?

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

Where Was This Sold?

This product was distributed to 2 states: MA, VA

Affected (2 states)Not affected

About Volk Optical Inc

Volk Optical Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report