FDA Medical Device Recalls (openFDA)
Gentell, Inc: Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - 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.
- Recall number
- Z-1910-2020
- Recalling firm
- Gentell, Inc
- Product
- Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - 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.
- Status
- Open, Classified
- Initiated
- 2020-03-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- During an FDA audit, it was discovered that the product was not properly registered with 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 vfalkenberg@gentell.com. 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 vfalkenberg@gentell.com. This will allow us to verify receipt of this letter
- Quantity
- 4,419
- Distribution
- Worldwide distribution - US Nationwide distributions and the country of South Africa.
- Lot, serial or model codes
- Lot Numbers: 1133718 1135318 1101019 1105819 1107119 1110619 1118219 1121119 1122119 1130319
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1000522686
- Firm city
- Bristol
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28