# FDA recall Z-0944-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-11-10.

## Product

EZDilate Wire Guided Balloon 18-19-20.  Indicated for endoscopic  dilation of strictures in the alimentary tract in adults and adolescents (>12 years).  Model: BD-410X-2055

## Reason for recall

Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

## Distribution

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

## Key facts

- **Recall number:** Z-0944-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-10
- **Report date:** 2024-02-07

- **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-0944-2024

## Citation

> AI Analytics. FDA recall Z-0944-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0944-2024. Source: US FDA. Licensed CC0.

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