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ASSIST Silver

MILLIKEN HEALTHCARE PDTS, LLC · Model 6"x6" · UDI-DI 00015961464396

FRO Prescription

510(k) clearances

3,144

Adverse events (63 deaths)

Recalls

383

Facilities

Description

ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound."

Recalls

Date	Firm	Reason
2026-06-08	ConvaTec, Inc	Surgical dressing manufactured out of specification (greater thickness).
2026-04-27	Oculus Technologies of Mexico, S.A. de C.V.	The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the produc
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-16	Integra LifeSciences Corp. (NeuroSciences)	Potential packaging failures, which could lead to a breach in the sterile barrier.
2026-01-05	Medline Industries, LP	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for
2026-01-05	Medline Industries, LP	Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.
2025-08-05	Integra LifeSciences Corp. (NeuroSciences)	Packaging failures were identified which could lead to a breach in the sterile barrier.

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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.