Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:36752
Brand Name:Aural Ventilation Tubes
Model:Shah Ventilation Tubes - none/PTFE/White/1.14/3.61/2.59/1.42/2.41
Affected:Lot number - 11998
Software version:
Recalling Organisation:Bio Serve NZ Limited
33 Morningside Drive
Morningside
Auckland
Contact Information:09 846 4802
Manufacturer:Exmoor Plastics Ltd
Issue:The manufacturer changed its steam sterilisation supplier for PTFE grommets and identified an issue during onboarding where a small number of units from certain lots showed visible sterile-barrier breaches during post-sterilisation inspection. A subsequent review of products from a specific sterilisation cycle found that sterility could not be confirmed with complete certainty, although the likelihood of a breach was assessed as less than 0.5%. As a precaution, a recall has been initiated for all affected lots.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/4/2026
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