Gentell recalls 100% honey wound dressings due to improper FDA registration. Affected products include specific model numbers and lot ranges. Consumers should contact the company for details.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell is recalling its Honey Hydrogel 2"x2" saturated gauze wound dressings because they were not properly registered with the FDA. This means the product may not meet safety standards and could pose risks if used without proper regulatory oversight.
The product was not properly registered with the FDA during an audit. This means it may not meet safety standards and could pose risks if used without proper regulatory oversight. However, the recall does not specify a direct hazard like injury or malfunction.
People who own or use the Gentell Honey Hydrogel 2"x2" saturated gauze wound dressings with the listed model number (GEN-11230) and specific lot numbers are affected. Those with wounds, diabetic skin ulcers, or other conditions treated with this product are most at risk.
Check for the model number GEN-11230 on the product packaging. The affected lot numbers include 1133718, 1135318, 1101019, 1102819, 1105819, 1107119, 1110619, 1116219, 1118219, 1121119, 1122119, 1123519, 1126319, and 1130319.
Look for the model number GEN-11230 and the specific lot numbers listed in the recall notice.
The product was not properly registered with the FDA during an audit, which means it may not meet safety standards.
The recall does not specify a remedy, so contact Gentell directly for guidance.
The recall does not describe a specific hazard mechanism, so the risk level is unknown.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1907-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1907-2020 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.
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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.
