Volk Optical Inc: Medical Device Recall in 2015 - (Recall #: Z-1685-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: February 27, 2015

Date Posted: June 3, 2015

Recall Number: Z-1685-2015

Event ID: 71014

Reason for Recall:

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

Status: Terminated

Product Quantity: 6 units

Code Information:

Model #V25LC, Lot: BE09243

Distribution Pattern:

Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated