WOM Tube Set (WOM) – Transponder Data Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
Brand
WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany
Lot Codes / Batch Numbers
UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Products Sold
UDI: 04056702003678 Lot Numbers: 4030902, 4030903
WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany is recalling WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in en due to Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Recommended Action
Per FDA guidance
Smith & Nephew Issued Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL WOM reference no.: 2024-0001 via email on 5/24/23. Letter states reason fo recall, health risk and action to take; lnform individuals within your organization who need to be aware of this recall. - Check all stock areas and/or operating room storage to determine if any tube sets with lol numbers from Annex 'l are at your facility, - Dispose of all affected tube sets properly. Confirm this on the customer response form. Return the form to fieldactions@smith-nephew.com. Please send any questions to fieldactions@smith-neDhew.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026