# FDA recall Z-1655-2023

> **Maquet Medical Systems USA** · Class II · device recall initiated 2023-05-18.

## Product

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                                 Item No. HMO 30000-USA               701070384 HMO 31000-USA               701070388

## Reason for recall

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

## Distribution

Nationwide domestic distribution

## Key facts

- **Recall number:** Z-1655-2023
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-06-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1655-2023

## Citation

> AI Analytics. FDA recall Z-1655-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1655-2023. Source: US FDA. Licensed CC0.

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