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Areza Medical

ADVANCED MEDICAL ASSOCIATES, LLC · Model SG4X43 · UDI-DI 00850021481254

NAD

510(k) clearances

18,954

Adverse events (8 deaths)

Recalls

514

Facilities

Description

Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel sheet made entirely from medical grade silicone. They are effective for the management of both existing and new, hypertrophic or keloid scars. Areza Silicone Gel Sheet for Scars may also be used as a prophylactic treatment on closed wounds to prevent hypertrophic or keloid scarring. Not intended to be used on open, unhealed wounds.

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.