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ULTRA Silver

MILLIKEN HEALTHCARE PDTS, LLC · Model 4"x5" · UDI-DI 00015961464372

FRO Prescription

510(k) clearances

3,144

Adverse events (63 deaths)

Recalls

383

Facilities

Description

ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ULTRA Silver dressings kill bacteria within the dressing and provides an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a polyester/ nylon wound contact layer coated with an ion-exchange silver, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with"Milliken" above and "ULTRA Silver" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.

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.