Gentell recalls Hydrogel Ag 2x2 model GEN-11220 due to improper FDA registration. Product used under healthcare professional supervision for wound care. No immediate action needed as it's a registration issue, not a safety hazard.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell is recalling its Hydrogel Ag 2x2 wound care product (model GEN-11220) because it wasn't properly registered with the FDA. This is a regulatory issue, not a safety hazard, so there's no need to stop using it.
The product wasn't properly registered with the FDA during an audit. This is a regulatory compliance issue, not a safety hazard that could cause injury or illness in normal use.
Healthcare professionals and patients using this product under medical supervision for wound care. Those most at risk are individuals with wounds needing specialized treatment.
Check for the model number GEN-11220 on the product packaging. This hydrogel is used under healthcare professional supervision for wounds like pressure ulcers or burns.
Verify the model number GEN-11220 on the packaging to confirm it's the recalled item.
No, this is a regulatory issue with FDA registration, not a safety hazard. The product is safe to use as intended.
No, the recall is for regulatory compliance, not safety. You can continue using it as directed by a healthcare professional.
Check the model number on the packaging. If it's GEN-11220, no action is needed since 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-1623-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1623-2020 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.
