Database updated: 28 November 2025

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:36249
Brand Name:FreeStyle Libre 3 Plus Continuous Glucose Monitoring System Sensor
Model:Product SKU: 78800-01
Affected:
Software version:
Recalling Organisation:Abbott Diabetes Care
Building D, 4 Pacific Rise
Mt. Wellington
Auckland
Contact Information:
Manufacturer:Abbott Diabetes Care Ltd
Issue:The manufacturer has recently identified that certain FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.
Patients with this device will be contacted individually via an in-app notification alerting them to the issue and instructing them to visit a website to determine whether they have affected product. If they do, they should not use the sensors and will be sent replacement units.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Public Recall
Date Commenced:26/11/2025
Additional Information:www.medsafe.govt.nz/hot/RecallActionNoticesNew/36249.asp
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