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

Recall Z-1625-2020 — Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin

U.S. FDA — Device Enforcement · United States · 2020-02-27 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1625-2020
Date of alert: 2020-02-27
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.

Related