Olympus Corporation of the Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name:

Recalling company

Olympus Corporation of the Americas

Product

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length

Reason

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 17, 2025

Reported

Nov 26, 2025

Distribution

US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.

Status

Ongoing

Quantity

60 units

Lot / codes

Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;

Company location

Center Valley, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-0572-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0572-2026 in the FDA Enforcement Report. Also see FDA recall press releases.