Dharma Research, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0476-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Dharma Cavity Varnish 15mL

Product Classification:

Class II

Date Initiated: September 29, 2014

Date Posted: December 3, 2014

Recall Number: Z-0476-2015

Event ID: 69386

Reason for Recall:

During an FDA inspection it was found that the products are marketed without a cleared 510k.

Status: Terminated

Product Quantity: 916

Code Information:

All Lots - Item # 14-00016

Distribution Pattern:

Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated