Amerx Health Care Corp.: Medical Device Recall in 2014 - (Recall #: Z-0497-2015)

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:

Amerigel Hydrogel Wound Dressing Wound management

Product Classification:

Class II

Date Initiated: September 26, 2014

Date Posted: December 10, 2014

Recall Number: Z-0497-2015

Event ID: 69394

Reason for Recall:

Formulation deviation

Status: Terminated

Product Quantity: 340,896

Code Information:

Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05

Distribution Pattern:

Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated