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Single-use Extraction Baskets

Scivita Medical Technology Co., Ltd. · Model EBF-1508CG · UDI-DI 06971381252811

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510(k) clearances

847

Adverse events (5 deaths)

Recalls

Facilities

Description

The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.

Recalls

Date	Firm	Reason
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2009-01-08	Boston Scientific Corp	The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to
2009-01-08	Boston Scientific Corp	The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to
2009-01-08	Boston Scientific Corp	The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to
2006-05-19	Boston Scientific Corp	Lack of assurance of sterility, as the sterile barrier may fail.
2006-05-19	Boston Scientific Corp	Lack of assurance of sterility, as the sterile barrier may fail.
2006-05-19	Boston Scientific Corp	Lack of assurance of sterility, as the sterile barrier may fail.
2006-05-19	Boston Scientific Corp	Lack of assurance of sterility, as the sterile barrier may fail.
2006-05-19	Boston Scientific Corp	Lack of assurance of sterility, as the sterile barrier may fail.

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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.