CLASS II ONGOING Device recall · Reported 13 May 2020 · FDA Enforcement Report

Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound recalled

Gentell is recalling Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing, distributed nationwide in the US. The recall was initiated on 26 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519

Quantity recalled4,348

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1909-2020
FDA event ID: 85373
Recalling firm: Gentell, Bristol, PA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Mar 2020
FDA classified: 6 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

26 Mar 2020	Recall initiated by company
6 May 2020	Classified by FDA	+41 days
13 May 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - 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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and recalled?

Yes. Gentell recalled Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and on 26 Mar 2020. The recall is Class II and its status is Ongoing. Recall number Z-1909-2020.

Why was it recalled?

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

Which lots are affected?

Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Gentell

All 11

Reported	Class	Recall	Company	Reason	Where
13 May 2020Device	CLASS II	Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound recalled	Gentell	Other	Nationwide
13 May 2020Device	CLASS II	Honey Hydrogel Hydrogel Tube recalled by Gentell	Gentell	Other	Nationwide
13 May 2020Device	CLASS II	Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound recalled	Gentell	Other	Nationwide
8 Apr 2020Device	CLASS II	Hydrogel Ag recalled by Gentell	Gentell	Other	Nationwide
8 Apr 2020Device	CLASS II	Hydrogel Ag recalled by Gentell	Gentell	Other	Nationwide

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