# FDA recall Z-2629-2023

> **WOM World Of Medicine AG** · Class II · device recall initiated 2023-07-17.

## Product

Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.  Models AQL-100PBS and AQL-100P

## Reason for recall

The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

## Distribution

Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE

## Key facts

- **Recall number:** Z-2629-2023
- **Recalling firm:** WOM World Of Medicine AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-17
- **Report date:** 2023-10-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2629-2023

## Citation

> AI Analytics. FDA recall Z-2629-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2629-2023. Source: US FDA. Licensed CC0.

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