Class II — Potential Health Hazard

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

Covidien HysteroLux Fluid Management System Control Unit Recalled by WOM World of Medicine AG Due to When the display of inflow volume to the...

Date: June 18, 2021
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

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

Quantity: 1100

Why Was This Recalled?

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.

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 3 total recalls tracked by RecallDetector.

Related Recalls

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