Gentell Hydrogel Ag 4x8 (model GEN-11820) is recalled due to improper FDA registration. This product is used for wound care under healthcare supervision. No action is required as the issue is a registration error, not a safety hazard.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell Hydrogel Ag 4x8 (model GEN-11820) is recalled because it wasn't properly registered with the FDA. This is a registration issue, not a safety hazard, so no action is needed.
The recall is based on an FDA audit finding that the product was not properly registered with the FDA. This is a regulatory compliance issue, not a safety hazard that could cause injury or damage.
Healthcare professionals using this product for wound care are likely affected. Patients using the product under medical supervision are not at risk due to the registration issue.
Check for the model number GEN-11820 on the product packaging. This hydrogel is used for wound care under healthcare professional supervision.
The product was not properly registered with the FDA, but this is a regulatory issue, not a safety hazard.
No, this is a registration issue with the FDA, not a safety hazard. No action is needed.
No, the recall is for regulatory compliance, not safety. You do not need to stop using it.
No action is required as this is a registration issue, not a safety hazard.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1625-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1625-2020 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.
