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 component: Bag deflector Recalled by WOM World of Medicine AG Due to The deficit displayed by the pump can differ...

Date: August 14, 2019
Company: WOM World of Medicine AG
Status: Terminated
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 component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

Quantity: 322 units

Why Was This Recalled?

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

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