Medtronic Ventilation Tube, Tympanostomy

Recalling firm
Medtronic New Zealand Limited
Product
Medtronic Ventilation Tube, tympanostomy. [Device]. Model: VENTILATION TUBE 5PK BUTTON 1.27 FLPL. Affected: Catalogue number: 1013301 Lot number: 0231048280
Reason
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.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-09-25
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/4624d763-d487-4dc7-9347-7bb4617fed3a