Stop using now Medical device recall · FDA · Published June 18, 2021

Covidien HysteroLux Fluid Management System Control Unit Recall: Display Freezes at 32450

Covidien recalls HysteroLux Fluid Management System Control Units with serial numbers starting 1803CE... that freeze display at 32450 ml, risking fluid distention. Stop using immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2561-2021Medical device Covidien ›

Stop using this now

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.

Take action

Contact the company

Recalling firmWOM World of Medicine AGSalzufer 8 · Berlin, Germany

✎ GovInfoNow plain-language explainer

Covidien is recalling specific HysteroLux Fluid Management System Control Units that may freeze their display when inflow reaches 32,450 ml, causing fluid to count backward and potentially distend soft tissues. This could lead to serious injury if the device is used as intended. Read more at govinfonow.com/recall/62328-covidien-hysterolux-fluid-management-system-control-unit-recall-display-freezes.

Source Summary by GovInfoNow · govinfonow.com/recall/62328-covidien-hysterolux-fluid-management-system-control-unit-recall-display-freezes · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2561-2021

Cite this page

“Covidien HysteroLux Fluid Management System Control Unit Recall: Display Freezes at 32450.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62328-covidien-hysterolux-fluid-management-system-control-unit-recall-display-freezes. Based on FDA recall #Z-2561-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2561-2021%22&limit=1).

WOM World of Medicine AG recalled Covidien HysteroLux Fluid Management System Control Units, REF: 72205000, due to a software error that freezes the inflow volume display at 32450 ml. The Food and Drug Administration announced the Class II recall on June 18, 2021.

How to tell if you have it

Brand: Covidien
Product: HysteroLux Fluid Management System Control Unit
REF: 72205000
Units affected: 1100

The hazard

The internal software calculation threshold causes the fluid management system control unit display to freeze when the inflow volume reaches 32450 ml. While outflow measurement continues, the deficit starts counting backwards to 0 ml, creating a risk of distention fluid reaching the soft tissue circulatory system.

Context

GovInfoNow's records show WOM World Of Medicine AG has issued four other recalls since October 22, 2018. On July 17, 2023, the company recalled an Aquilex Fluid Control System because its display could freeze at 30,000 ml, potentially causing fluid overload. Other recent recalls of similar products include Olympus UHI-4 Insufflation Unit Recall (June 16, 2026), Philips PIC iX Essentials Software Freezes (July 31, 2026), and ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026).

How to tell if you have this one

Check the serial number on the control unit. The recalled units have serial numbers starting with 1803CE, 1804CE, 1805CE, 1806CE, 1807CE, 1808CE, 1809CE, or 1901CE, followed by specific digits as listed in the recall.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the control unit if it has a serial number listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of CT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 4 months after the firm started it.

Jun 18, 2021Firm started the recall
Sep 24, 2021FDA classified it Class II
Oct 6, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/62328-covidien-hysterolux-fluid-management-system-control-unit-recall-display-freezes">Covidien HysteroLux Fluid Management System Control Unit Recall: Display Freezes at 32450 (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2561-2021 (June 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2561-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.