Home › ADVANCED MEDICAL ASSOCIATES, LLC › Areza Medical

Areza Medical

ADVANCED MEDICAL ASSOCIATES, LLC · Model BG8430 · UDI-DI 00850021481674

NAD

510(k) clearances

18,954

Adverse events (8 deaths)

Recalls

511

Facilities

Description

Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self-adhesive dressing. The central pad (6"x4") is composed of non-woven viscose fibers which on the facing surface are covered with a fenestrated non-adherent layer. The backing of the dressing (8"x6") is made of polyurethane and Spunlace fabric and is covered with adhesives. The non-adherent wound-facing layer provides this dressing the unique ability to be used on minimally exuding wounds. This conformable dressing may reduce the risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.