Gentell recalls 4oz Hydrogel Ag tubes due to improper FDA registration. This affects wound care products used under healthcare professional supervision.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell is recalling its 4oz Hydrogel Ag wound dressing tubes because they weren't properly registered with the FDA. This means the product may not meet safety standards for medical use.
The product wasn't properly registered with the FDA during an audit. This could mean it doesn't meet required safety standards for medical use, though no injuries were reported.
Healthcare professionals using this product for wound care are most affected. Patients using the product under medical supervision may also be impacted.
Check for the 4oz Hydrogel Ag tube with model number listed in the product description. The product is intended for use under healthcare professional supervision.
Verify the product was registered with the FDA as required by the manufacturer.
The FDA audit found improper registration, but no injuries were reported. The product may still be safe for use under healthcare professional supervision.
No immediate action is required. The product is intended for use under healthcare professional supervision and may be safe if properly registered.
Look for the 4oz Hydrogel Ag tube with model number listed in the product description.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1626-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1626-2020 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.
