Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aquilex Fluid Control System-Intended to provide fluid distension of the Recalled by WOM World Of Medicine AG Due to The display of inflow volume can reach its...

Date: July 17, 2023
Company: WOM World Of Medicine AG
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact WOM World Of Medicine AG directly.

Affected Products

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

Quantity: 1287 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About WOM World Of Medicine AG

WOM World Of Medicine AG has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report