# FDA recall Z-1635-2023

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

## Product

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass  Item no. 701067859

## Reason for recall

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas.   Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

## Distribution

Domestic distribution nationwide.

## Key facts

- **Recall number:** Z-1635-2023
- **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-1635-2023

## Citation

> AI Analytics. FDA recall Z-1635-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1635-2023. Source: US FDA. Licensed CC0.

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