FDAClass IIMay 13, 2020

Gentell Honey Hydrogel 2"x2" Saturated Gauze- A recall

Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model…

Why was Gentell Honey Hydrogel 2"x2" Saturated Gauze- A recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model…
Recalling firm
Gentell, Inc
Quantity
85,586
Distribution
Worldwide distribution - US Nationwide distributions and the country of South Africa.
Recall date
May 13, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls