# FDA recall Z-1754-2025

> **Numed Inc** · Class II · device recall initiated 2025-04-21.

## Product

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

## Reason for recall

Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

## Distribution

US distribution to Pennsylvania.

## Key facts

- **Recall number:** Z-1754-2025
- **Recalling firm:** Numed Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2025-04-21
- **Report date:** 2025-05-21
- **Termination date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hopkinton, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1754-2025

## Citation

> AI Analytics. FDA recall Z-1754-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1754-2025. Source: US FDA. Licensed CC0.

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