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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

WOM World Of Medicine AG: Aquilex Fluid Control System Recalled for Fluid Overload Risk

Agency Publication Date: January 5, 2024
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Summary

Approximately 1,287 Aquilex Fluid Control Systems are being recalled because the device's inflow volume display can freeze after reaching 30,000 ml during long medical procedures. When this limit is hit, the fluid deficit counter begins counting backward toward zero, which can lead to medical staff incorrectly monitoring fluid levels. This defect could result in a patient receiving too much fluid (fluid overload) during uterine procedures. Consumers and medical facilities using models AQL-100PBS and AQL-100P should contact the manufacturer, WOM World Of Medicine AG, for further instructions.

Risk

The software error causes the volume monitor to freeze at a maximum value and reverse the deficit count, which can mislead surgical teams into thinking less fluid has been absorbed by the patient than is actually the case. This specific failure mechanism poses a risk of fluid overload, a serious medical condition that can lead to pulmonary edema or other cardiovascular complications.

What You Should Do

  1. Identify if your facility is using the Aquilex Fluid Control System, specifically models AQL-100PBS or AQL-100P.
  2. Check the serial numbers on your devices against the extensive list of affected units, which include hundreds of US serial numbers beginning with 'S1802', '1803', '1804', '1805', up to '2303' (e.g., S1802CE0538, 2303CE0661).
  3. Verify the device's UDI-DI code is 04056702006914 to confirm it is part of this recall.
  4. Be especially vigilant during long procedures where fluid inflow may approach 30,000 ml; if the display freezes or the deficit begins counting backward, recognize this as a system error and monitor the patient for signs of fluid overload.
  5. Contact your healthcare provider or the manufacturer, WOM World Of Medicine AG, for further instructions and information regarding a potential fix or replacement for the software defect.
  6. For additional questions, contact the FDA medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Aquilex Fluid Control System
Model / REF:
AQL-100PBS
AQL-100P
UPC Codes:
04056702006914
Lot Numbers:
US Serial Numbers: S1802CE0538
1802CE0539
1802CE0540
1802CE0542
1802CE0543
1802CE0544
1802CE0545
1802CE0546
1802CE0547
1802CE0616
1802CE0617
1802CE0618
1802CE0619
1802CE0620
1802CE0621
1802CE0622
1802CE0624
1802CE0625
1802CE0648
1802CE0649
1802CE0651
1802CE0652
1802CE0653
1802CE0654
1802CE0655
1802CE0656
1802CE0657
1803CE0121
1803CE1022
1904CE0114
2006CE0477
2109CE1026
2209CE0766
2303CE0661
Canada Serial Numbers: 1802CE0650
1803CE0302
2104CE0706

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92938
Status: Active
Manufacturer: WOM World Of Medicine AG
Sold By: Authorized medical device distributors; Hospitals; Surgical centers
Manufactured In: Germany
Units Affected: 1287 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.