Reported May 13, 2020 · Ongoing

Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey),…

Gentell, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gentell, Inc · 2701 Bartram Rd · Bristol, PA · 19007-6810

Is this the product you have?

  • Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey)
  • Model NumberGEN-11340 -
  • Product UsageUse 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
Lot codes and dates
  • Lot Numbers
    • 1133718
    • 1135318
    • 1101019
    • 1105819
    • 1107119
    • 1110619
    • 1118219
    • 1121119
    • 1122119
    • 1130319
Amount recalled
4,419

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.