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ComfortGauze Border

Sion Brands LLC · Model 42262 · UDI-DI 01714196422629

NAC

510(k) clearances

1,404

Adverse events (6 deaths)

Recalls

501

Facilities

Description

DermaRite’s ComfortGauze™ Border offers the simple and reliable protection and absorption of bordered gauze, with the addition of a gentle, silicone, adhesive layer that makes dressing removal safer and more comfortable for compromised or at-risk skin.

Recalls

Date	Firm	Reason
2026-05-18	DeRoyal Industries Inc	Sterile wound dressing, lacks sterility assurance
2025-02-19	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for the sterility of the device to be compromised.
2024-10-01	Advanced Medical Solutions Ltd.	Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
2024-10-01	Advanced Medical Solutions Ltd.	Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
2024-10-01	Advanced Medical Solutions Ltd.	Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
2024-02-27	ConvaTec, Inc	The product does not meet sterility assurance level.
2024-01-23	MEDLINE INDUSTRIES, LP - Northfield	Product failed sterility testing.
2016-06-08	Amd-Ritmed, Inc.	The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.
2004-01-19	DeRoyal Surgical Tray	Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.