Z-2243-2024Class II

WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic...

Name: Z-2243-2024 WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic...
Creator: WOM World Of Medicine AG
Published: 2024-05-24
License: https://open.fda.gov/license/

Novanta Medical GmbH / initiated 2024-05-24 / Open, Classified / root cause: manufacturing process

FDA source

WOM World Of Medicine AG began a recall of WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc... on 2024-05-24. FDA classified it as Class II and gives the reason as "Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2243-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-24
Posted: 2024-07-01
Recalling firm: Novanta Medical GmbH
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
Product code: HRX Arthroscope
Reason for recall: Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. Please send any questions to [email protected]
Quantity in commerce: 1700 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI: 04056702003678 Lot Numbers: 4030902, 4030903

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-01

Product code HRX

K062380Class IIFlosimple Arthroscopy Pump A120W.O.M. World of Medicine AG / cleared 2006-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)