Gentell, Inc 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Gentell, Inc
Lot Codes / Batch Numbers
Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519
Products Sold
Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519
Gentell, Inc is recalling Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and hon due to During an FDA audit, it was discovered that the product was not properly registered with FDA.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026