Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Gentell Hydrogel Ag Saturated Gauze Recalled by Gentell, Inc Due to CGMP Deviations

Date: December 15, 2016
Company: Gentell, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Gentell, Inc directly.

Affected Products

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007

Quantity: 3,000 gauzes

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

United States

About Gentell, Inc

Gentell, Inc has 11 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report