Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 dilatat — recall Z-0572-2026

U.S. FDA — Device Enforcement · United States · 2025-10-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0572-2026
Date of alert: 2025-10-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00821925033016

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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