# FDA recall Z-0572-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-10-17.

## 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 for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-0572-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-17
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0572-2026

## Citation

> AI Analytics. FDA recall Z-0572-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0572-2026. Source: US FDA. Licensed CC0.

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