Olea Sphere V3.0 (2019-04-16)

Olea Sphere V3.0 Recall Summary The Olea Sphere V3.0 medical device was recalled across Canada on April 16, 2019, due to safety concerns classified as Class I, the most serious type of recall. This recall affects all Canadian users of this device. The specific details about what the device is used for and the exact nature of the safety issue are not provided in the information given.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-05-10

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ecf3b9d5-c079-4004-946a-22385f558671