VIA

US Endoscopy · Model 00717007 · UDI-DI 00724995181000

NWU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The VIA Procedure Kit - custom includes: basin, transport pad, gauze pads, suction tubing, Biohazard Sticker, Solidifier, Water and Detergent label, enzymatic sponge, Lubricating Jelly, gowns, DuoSwift combination squeegee brush, Defendo air water and suction valves, BioShield biopsy valve and ENDOGATOR Water Jet Connector for Olympus Endoscopes.

Recalls

Date	Firm	Reason
2026-08-18	Cardinal Health 200, LLC	The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl
2026-07-29	Cardinal Health 200, LLC	The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is
2026-03-19	Medline Industries, LP	During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o
2025-09-04	American Contract Systems Inc.	Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not
2025-07-14	American Contract Systems Inc	During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further
2025-02-11	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may
2025-02-06	American Contract Systems Inc	ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-02-06	American Contract Systems Inc	ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
2025-01-31	American Contract Systems, Inc.	Sterility assurance with procedure trays
2024-11-21	MEDLINE INDUSTRIES, LP - Northfield	Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

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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.