Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28271
Brand Name:56653-IIa
Model:
Affected:Batch numbers - 100131, 500161, 500172, 500214, 500307, 500319, 500355
Software version:
Recalling Organisation:KARL STORZ Endoscopy New Zealand Limited
31 Morningside Drive
Mt Albert
AUCKLAND 1025
Contact Information:
Manufacturer:Karl Storz SE & Co KG
Issue:The manufacturer has identified that the required sterility assurance level was not achieved during recent testing of the sterilization process performed by our contract sterilizer. This testing was initiated as a result of a regular requalification review. The affected products therefore may not be sterile as claimed.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:1/9/2021
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