Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1909-2020 — Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-deg

U.S. FDA — Device Enforcement · United States · 2020-03-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1909-2020
Date of alert: 2020-03-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Gentell, Inc
Product category: device
Product type: Devices

Reported risk: During an FDA audit, it was discovered that the product was not properly registered with FDA.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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