Z-1626-2020Class II

Gentell Hydrogel Ag 4oz. Tube, model no. -

Name: Z-1626-2020 Gentell Hydrogel Ag 4oz. Tube, model no. -
Creator: Gentell, Inc
Published: 2020-02-27
License: https://open.fda.gov/license/

Gentell / initiated 2020-02-27 / Open, Classified

FDA source

Gentell, Inc began a recall of Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing... on 2020-02-27. 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-1626-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-02-27
Posted: 2020-03-05
Recalling firm: Gentell
Product: Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing 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.
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: On February 27, 2020, the firm notified customers by distributing Urgent Medical Device Recall letters. Customers were informed that the products were not properly registered with the FDA, and that the firm is discontinuing the product permanently. Customers were asked to quarantine and return the product. To return product, customers are to complete the response form included with the letter and fax or email it back to the firm. A quality representative will contact customers with a return goods authorization number, provide instruction for the return of the product(s) to Gentell, and arrange for any refund that may be due. The response form should be completed and returned even if customers have no affected stock on hand. Customers with questions should contact Valerie Falkenberg, Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time, 800-840-9041 or [email protected].
Quantity in commerce: 6,395
Distribution: 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.
Product codes and lots: 1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1121419 1124919

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1626-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-08	2020-04-01
Z-1624-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-08	2020-04-01
Z-1625-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-08	2020-04-01
Z-1626-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-08	2020-04-01

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)