---
title: "Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Pr... — FDA record Z-0572-2026 | Is It on Recall"
description: "Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon cathe"
url: https://isitonrecall.com/recall/fda-device-z-0572-2026-brand-name-ezdilate-nephrostomy-balloon-catheter-and-inflation-device-kit-product-name-olympus-nephr/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Neph... — FDA record Z-0572-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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
- **Recalling firm**: Olympus Corporation of the Americas
- **Quantity**: 60 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0572-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0572-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
- [California](https://isitonrecall.com/state/california/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Nov 26, 2025
- **Recall initiation date**: Oct 17, 2025
- **Center classification date**: Nov 20, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0572-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Olympus Corporation of the Americas records](https://isitonrecall.com/brand/olympus-corporation-of-the-americas/)