RecallRadar

FDA Device recall Z-2243-2024

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

On 2024-07-10 the FDA classified a Class II recall of WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries by Wom World, citing incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2243-2024
ClassificationClass II
Statusongoing
Initiated2024-05-24
Published2024-07-10
Last updated2026-09-13 11:57 UTC
CompanyWom World
DistributionUS

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

Reason

Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

Identifiers

code_infoUDI: 04056702003678 Lot Numbers: 4030902, 4030903

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2243-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.