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Areza Medical

ADVANCED MEDICAL ASSOCIATES, LLC · Model ST15501 · UDI-DI 00850021481636

KGX

510(k) clearances

5,063

Adverse events (16 deaths)

Recalls

983

Facilities

Description

AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoallergenic nature and ease of removal make it an ideal tape for patients with fragile skin or sensitivity to acrylic adhesives. Areza Silicone Tape consists of a polyurethane film carrier (backing) and a potent adhesive silicone gel. The combination of strong adhesion and skin-friendliness makes this tape ideal for applications requiring a secure hold without causing skin irritation. This tape finds versatile applications in various healthcare settings and conditions, providing extended wear time. It is commonly used in wound care, post-surgery recovery, and medical device fixation, among other healthcare applications.

Recalls

Date	Firm	Reason
2025-12-26	GOLD STAR DISTRIBUTION INC	Potential exposure of rodents and rodent activity in the distribution center.
2025-11-25	Ferndale Laboratories, Inc.	Butyrate tube cracks during actuation, rendering product unusable.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2024-04-17	Cardinal Health 200, LLC	Potential contamination of the product with latex adhesive residual.

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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.