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Medifoam

Genewel Co.,Ltd. · Model 12NL02 · UDI-DI 08806129660031

NAC

510(k) clearances

1,440

Adverse events (6 deaths)

Recalls

501

Facilities

Description

Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasions, etc. It readily absorbs exudate, providing a moist wound interface that produces an optimal wound healing environment. To help adhesion, a non-woven fabric for fixation is enclosed with the product. Medifoam is a sterile, but Non-woven fabric is a non-sterile. This is single-use product, do not re-use. This product does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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.