Gentell, Inc: Medical Device Recall in 2020 - (Recall #: Z-1623-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

Product Classification:

Class II

Date Initiated: February 27, 2020

Date Posted: April 8, 2020

Recall Number: Z-1623-2020

Event ID: 85034

Reason for Recall:

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Status: Ongoing

Product Quantity: 53,134

Code Information:

1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

Distribution Pattern:

Worldwide distribution US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

Voluntary or Mandated:

Voluntary: Firm initiated