Gentell recalls 100% honey wound dressings due to improper FDA registration. Affected lots include 1133718, 1135318, and others. Consumers should check product labels for lot numbers.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell is recalling its Honey Hydrogel 4"x4" saturated gauze wound dressings because they were not properly registered with the FDA. This issue does not pose a direct health risk but requires action to ensure compliance with regulatory standards.
The product was not properly registered with the FDA during an audit. This means it may not meet regulatory standards, but the recall does not indicate immediate health risks like injury or illness.
Users of Gentell Honey Hydrogel 4"x4" saturated gauze wound dressings with lot numbers listed in the recall notice. People with wounds, diabetic skin ulcers, or post-surgical incisions are most at risk if they use the affected products.
Check the product label for the model number GEN-11430 and lot numbers: 1133718, 1135318, 1101019, 1102819, 1105819, 1107119, 1110619, 1116219, 1118219, 1121119, 1122119, 1123519, 1126319, 1130319.
Look for the model number GEN-11430 and lot numbers listed in the recall notice.
The product was not properly registered with the FDA during an audit.
Check the product label for the model number GEN-11430 and lot numbers. If it matches, contact Gentell for instructions.
The recall does not indicate a direct health risk, but the product was not properly registered with the FDA.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1908-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1908-2020 from Gentell. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
