WOM Tube Set for Irrigation Recalled Due to RFID Tag Data Error
WOM Tube Set for Irrigation (1700 units, Lots 4030902 and 4030903) is recalled due to incorrect RFID tag data that causes an error message preventing use in endoscopic surgeries, potentially resulting in surgical delays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a functional defect in RFID transponder data causing product rejection and operational delays rather than direct patient safety risk.
Plain-English summary
WOM World Of Medicine AG is recalling 1700 units of the WOM Tube Set for Irrigation due to incorrect transponder data written on RFID tags. The product is a single-use medical device intended to transport irrigation fluid to patients during endoscopic surgeries and is distributed nationally in the United States through Endoscopy Smith & Nephew Inc.
The incorrect RFID tag data triggers an error message (E03) that marks the tube set as invalid. This prevents the device from being used as intended and may result in delays to surgical procedures.
The affected lot numbers are 4030902 and 4030903, identifiable by UDI 04056702003678. Healthcare facilities should check their inventory for these lot numbers immediately.
Facilities with affected inventory should contact WOM World Of Medicine AG or Endoscopy Smith & Nephew Inc. for instructions on returning the defective units and obtaining replacement products.
The recalled product
- 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
- Manufacturer
- WOM World Of Medicine AG
- Hazard
- rfid-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 04056702003678 Lot Numbers: 4030902
- 4030903
Distribution
Distributed nationwide across the United States.
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