Kova Laboratories, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1992-2014)

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:

Amerigel Wound Dressing 1 oz. tube

Product Classification:

Class II

Date Initiated: March 21, 2014

Date Posted: July 16, 2014

Recall Number: Z-1992-2014

Event ID: 68488

Reason for Recall:

Product may not have been manufactured pursuant to a validated process protocol and CGMP.

Status: Terminated

Product Quantity: 122,396 / 1oz. tubes

Code Information:

Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.

Distribution Pattern:

Distributed in the states of FL and NJ.

Voluntary or Mandated:

Voluntary: Firm initiated