Gentell recalls honey hydrogel wound dressings due to improper FDA registration. Affected lots include 1133718, 1135318, and others. No action needed as the product is safe but must be registered with FDA.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell is recalling honey hydrogel wound dressings that weren't properly registered with the FDA. This doesn't make the product unsafe for use but means it's not legally registered with the FDA.
The product wasn't properly registered with the FDA during an audit. This means it's not legally compliant but doesn't cause harm to users directly.
Wound care users who own the Gentell Honey Hydrogel 4"x8" Saturated Gauze with lot numbers listed in the recall. People with diabetic ulcers, burns, or minor wounds may be most affected.
Check the lot number on the packaging: 1133718, 1135318, 1101019, 1102819, 1110619, 1116219, 1118219, 1121119, 1122119, or 1123519. The product is a honey hydrogel wound dressing with model number GEN-11830.
The product was not properly registered with the FDA, but it is safe to use as the issue is administrative.
No, the product is safe but not properly registered with the FDA. It does not pose a direct health risk.
No action is needed as the product is safe. The recall is due to an administrative issue with FDA registration, not a safety hazard.
Check the lot number on the packaging: 1133718, 1135318, 1101019, 1102819, 1110619, 1116219, 1118219, 1121119, 1122119, or 1123519.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1909-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1909-2020 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.
