# FDA recall Z-0225-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-09-13.

## Product

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.    Model/Catalog Number: BD-410X-1055

## Reason for recall

Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery.  All other labeling is correct for the balloon, including the  Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch

## Distribution

Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.

## Key facts

- **Recall number:** Z-0225-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-13
- **Report date:** 2024-10-30

- **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-0225-2025

## Citation

> AI Analytics. FDA recall Z-0225-2025. Retrieved 2026-09-16 from https://api.ai-analytics.org/recall/Z-0225-2025. Source: US FDA. Licensed CC0.

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