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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/Surgical Equipment

WOM World Of Medicine AG: Irrigation Tube Sets Recalled for Incorrect RFID Data and Surgery Delays

Agency Publication Date: July 1, 2024
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Summary

WOM World Of Medicine AG has recalled approximately 1,700 WOM Tube Sets for Irrigation used in endoscopic surgeries. These single-use devices, distributed by Endoscopy Smith & Nephew Inc., were manufactured with incorrect transponder data on their RFID tags. This defect triggers an "E03 Tube Set Invalid" error message when the device is connected to surgical equipment, which can lead to unexpected delays during medical procedures. Consumers should identify affected units by the reference number T0449-01 and specific lot numbers 4030902 or 4030903.

Risk

The incorrect RFID data causes the surgical irrigation system to reject the tube set as invalid, resulting in an error message that prevents the device from functioning. This failure can cause a delay in surgery while staff attempt to troubleshoot or replace the equipment, potentially increasing the time a patient is under anesthesia or prolonging the surgical procedure.

What You Should Do

  1. Check your inventory for WOM Tube Sets for Irrigation (single-use) with REF Number T0449-01 and UDI 04056702003678.
  2. Verify if your product matches Lot Numbers 4030902 or 4030903.
  3. If you identify an affected tube set, do not attempt to use it in a surgical procedure, as it will likely trigger an 'E03' error and cause delays.
  4. Contact your healthcare provider or the manufacturer, WOM World Of Medicine AG, for further instructions on how to return affected units or obtain replacements.
  5. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer or healthcare provider contact

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

Affected Products

Product: WOM Tube Set for Irrigation, single-use
Model / REF:
T0449-01
UPC Codes:
04056702003678
Lot Numbers:
4030902
4030903

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94749
Status: Active
Manufacturer: WOM World Of Medicine AG
Sold By: Endoscopy Smith & Nephew Inc.
Manufactured In: Germany
Units Affected: 1700 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.