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Areza Medical

ADVANCED MEDICAL ASSOCIATES, LLC · Model FADWR6.5 · UDI-DI 00850021481278

NAD

510(k) clearances

18,954

Adverse events (8 deaths)

Recalls

514

Facilities

Description

Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a central polyurethane (PU) foam pad with a size of 4.1” x 4.1” and 5 mm thickness. Foam pad to lay on exuding wounds and is non-adhesive as long as it is used on actively exuding wounds. 2- a very thin PU backing layer which is soft, white in color, breathable, and reinforced with Spunlace, nonwoven fabric mesh. Note: this layer provides water resistance, but it is not waterproof. Meaning liquid may cross from the outer surface to the inside with some delay (normally about 10-20 mins or longer). Unless the foam is soaked, exudate does not cross from the inner surface to outer surface. This dressing is not suitable for showering or swimming. 3- an adhesive layer composed of medical grade Henkel glue that is adhered onto the second layer, the Spunlace, nonwoven fabric mesh.

Recalls

Date	Firm	Reason
2025-08-29	ConvaTec, Inc	Wound dressing may have foreign matter on the product.
2025-02-19	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for the sterility of the device to be compromised.
2022-01-28	Sam Medical Products	Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov
2021-08-20	ConvaTec, Inc	Primary packaging labeling may be incorrect.
2021-08-09	ConvaTec, Inc	There is a potential for open seals which can compromise sterility.
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect

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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.