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SiOxC

Sioxmed, LLC · Model SBC1, 8 Oz, 1 Unit · UDI-DI 00850021883065

FRO Prescription

510(k) clearances

3,144

Adverse events (63 deaths)

Recalls

383

Facilities

Description

SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a moist skin environment. SBC1 is comprised of a base cream (Prime Matter) mixed with milled silica-based fibers (SBF-1 and SBF-M1, described in MAF 3558), the same fibers used to make SiOxD Wound Matrix fibers (previously cleared in 510(k) submissions K222189, K232847, and K241660) to improve the texture of the cream. SBC1 is provided for prescription use only in 1- and 8-ounce jars for single patient use. The volumes offered in both container sizes are intended to be sufficient for multiple applications of the product to the treatment area(s) by a single patient.

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.