Gentell, Inc: Medical Device Recall in 2020 - (Recall #: Z-1907-2020)

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 Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.

Product Classification:

Class II

Date Initiated: March 26, 2020

Date Posted: May 13, 2020

Recall Number: Z-1907-2020

Event ID: 85373

Reason for Recall:

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

Status: Ongoing

Product Quantity: 85,586

Code Information:

Lot Numbers: 1133718 1135318 1101019 1102819 1105819 1107119 1110619 1116219 1118219 1121119 1122119 1123519 1126319 1130319

Distribution Pattern:

Worldwide distribution - US Nationwide distributions and the country of South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated