Sphere-9™ Catheter

Sphere-9™ Catheter Recall The Sphere-9™ Catheter is being recalled across Canada due to a device performance issue. This is a Class I recall, which indicates a serious problem with how the device functions. The recall affects all Sphere-9™ Catheters distributed throughout Canada.

Product

Sphere-9™ Catheter

Reason

Device performance issue

Classification

Class I

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-07-27

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c24515eb-b8f8-4b58-92aa-9d9cbea2cdd0