Z-1908-2020Class II

Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100%...

Name: Z-1908-2020 Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100%...
Creator: Gentell, Inc
Published: 2020-03-26
License: https://open.fda.gov/license/

Gentell / initiated 2020-03-26 / Open, Classified

FDA source

Gentell, Inc began a recall of Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 -... on 2020-03-26. FDA classified it as Class II and gives the reason as "During an FDA audit, it was discovered that the product was not properly registered with FDA". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1908-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-26
Posted: 2020-05-06
Recalling firm: Gentell
Product: Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - 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 code: FRO Dressing, Wound, Drug
Reason for recall: During an FDA audit, it was discovered that the product was not properly registered with FDA.
FDA root cause: No Marketing Application
Action: Gentell issued Urgent Medical Device Recall letter dated 3/26/20 mailed March 27, 2020 via first class US Mail stating reason for recall, health risk and action to take: 1.If you have the affected stock, discontinue use and quarantine the products that contain any of the listed lot numbers. 2. To return product, complete the enclosed "Acknowledgement and Receipt Form" and fax to 215-788-2715 or email to [email protected]. A quality representative will contact you with a return goods authorization number (RGA#), provide instruction for the return of the product(s) to Gentell, and arrange for any refund that may be due. 3. If you have no affected stock, please complete the enclosed "Recall Acknowledgement Form" and fax to 215-788-2715 or email to [email protected]. This will allow us to verify receipt of this letter
Quantity in commerce: 22,439
Distribution: Worldwide distribution - US Nationwide distributions and the country of South Africa.
Product codes and lots: Lot Numbers: 1133718 1135318 1101019 1102819 1105819 1107119 1110619 1116219 1118219 1121119 1122119 1123519 1126319 1130319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1908-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1907-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-06
Z-1908-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-06
Z-1909-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-06
Z-1910-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-06

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)