Class III — Low Risk

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

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during Recalled by Volk Optical Inc Due to The defect was with mis-engraving of the lot...

Date: October 25, 2012
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

20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Quantity: 40 devices

Why Was This Recalled?

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).

Where Was This Sold?

This product was distributed to 6 states: AZ, CA, GA, MN, NJ, NM

Affected (6 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