Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:37638
Brand Name:Medtronic Ventilation Tube, tympanostomy
Model:VENTILATION TUBE 5PK BUTTON 1.27 FLPL
Affected:Catalogue number: 1013301 Lot number: 0231048280
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:Medtronic Xomed
Issue:The manufacturer is recalling a certain lot of Ventilation Tubes (Catalogue Number: 1013301) due to the impacted product not being subjected to the required sterilisation process which after implantation could cause infection and subsequent inflammation potentially leading to temporary hearing impairment, otorrhea (fluid discharge) and the need for antibiotics.. The recall impacted lot number is 0231048280.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:25/9/2026
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