Gentell Honey Hydrogel 4oz tubes (model GEN-11340) were recalled due to improper FDA registration. This affects specific lot numbers for wound dressings used on minor wounds and ulcers.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell is recalling 4oz honey hydrogel wound dressings because they were not properly registered with the FDA. This means the product may not meet safety standards, but it does not pose an immediate physical risk to users.
The product was not properly registered with the FDA during an audit. This means it may not meet safety standards, but it does not cause physical harm like injuries or fires. The issue is a regulatory compliance problem, not a direct hazard to users.
Users of Gentell Honey Hydrogel 4oz tubes with specific lot numbers (1133718, 1135318, etc.) are affected. People using the product for minor wounds, ulcers, or burns are most at risk.
Check the lot number on the tube, which is listed as 1133718, 1135318, 1101019, 1105819, 1107119, 1110619, 1118219, 1121119, 1122119, or 1130319. The product is a 4oz tube labeled as Gentell Honey Hydrogel for wound dressings.
Look for the lot number on the tube, which should be one of the listed numbers: 1133718, 1135318, 1101019, 1105819, 1107119, 1110619, 1118219, 1121119, 1122119, or 1130319.
The product was not properly registered with the FDA during an audit, so it may not meet safety standards.
No, the recall is due to a regulatory issue, not a physical hazard like injury or fire.
Check the lot number to see if it's affected; if it is, you can safely discard it or contact Gentell for more information.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1910-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1910-2020 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.
