# FDA recall Z-1765-2022

> **Maquet Medical Systems USA** · Class II · device recall initiated 2022-07-22.

## Product

BEQ-HLS 5050 USA;    HLS Set Advanced 5.0    Part No. 70105.2797.    A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

## Reason for recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

## Distribution

Worldwide distribution - US Nationwide and the countries Canada and Australia.

## Key facts

- **Recall number:** Z-1765-2022
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-22
- **Report date:** 2022-09-28

- **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-1765-2022

## Citation

> AI Analytics. FDA recall Z-1765-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1765-2022. Source: US FDA. Licensed CC0.

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