CLASS II ONGOING Device recall · Reported 8 Apr 2020 · FDA Enforcement Report

Hydrogel Ag recalled by Gentell

Gentell is recalling Gentell Hydrogel Ag, distributed nationwide in the US. The recall was initiated on 27 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

Quantity recalled20,025

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-1624-2020
FDA event ID: 85034
Recalling firm: Gentell, Bristol, PA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Feb 2020
FDA classified: 1 Apr 2020
Reported: 8 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Feb 2020	Recall initiated by company
1 Apr 2020	Classified by FDA	+34 days
8 Apr 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 Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

Where it was distributed

Worldwide distribution US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

Nationwide Alabama California Florida Iowa Illinois Kentucky Massachusetts Michigan Minnesota North Carolina New Jersey New York Ohio Oklahoma Pennsylvania Puerto Rico Rhode Island South Carolina Tennessee Texas

Questions about this recall

Is Hydrogel Ag recalled?

Yes. Gentell recalled Hydrogel Ag on 27 Feb 2020. The recall is Class II and its status is Ongoing. Recall number Z-1624-2020.

Why was it recalled?

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

Which lots are affected?

1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919

Where was it sold?

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 4"x8" Saturated Gauze- A hydrating wound recalled	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

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