# FDA recall Z-0311-2025

> **Datascope Corp.** · Class II · device recall initiated 2024-09-17.

## Product

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-  0295-01

## Reason for recall

There is discrepant labeling on the inner and outer packaging of the device.

## Distribution

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.

## Key facts

- **Recall number:** Z-0311-2025
- **Recalling firm:** Datascope Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-17
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fairfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0311-2025

## Citation

> AI Analytics. FDA recall Z-0311-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0311-2025. Source: US FDA. Licensed CC0.

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