Optima Mr360

Optima MR360 Recall Summary The Optima MR360 drug product is being recalled across Canada due to an increased risk of adverse events. This is a Class I recall, which is the most serious classification level. The recall affects all Optima MR360 products distributed throughout Canada.

Product
Optima MR360
Reason
Increased risk or new adverse events
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-03-21
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ac36cb8c-5dec-413e-8fc1-bf470eb4e018