# FDA recall Z-2561-2021

> **WOM World of Medicine AG** · Class II · device recall initiated 2021-06-18.

## Product

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

## Reason for recall

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

## Distribution

US Nationwide distribution in the state of CT.

## Key facts

- **Recall number:** Z-2561-2021
- **Recalling firm:** WOM World of Medicine AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-18
- **Report date:** 2021-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2561-2021

## Citation

> AI Analytics. FDA recall Z-2561-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-2561-2021. Source: US FDA. Licensed CC0.

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