ViziShot 2 Flex
Brand(s)
Last updated
Summary
Product
ViziShot 2 Flex
Issue
Medical devices - Labelling and packaging
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| ViziShot 2 Flex | More than 10 numbers, contact manufacturer. | NA-U403SX-4019 |
Issue
Olympus is removing certain ViziShot 2 Flex (19g) devices due to a potential patient safety issue. Customers should not use any of the affected devices listed in the medical device recall letter and should return any affected products. Olympus is also reinforcing existing warnings in the Instructions for Use (IFU).
Recall start date: August 13, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
| Gyrus Acmi, Inc |
| 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77960
Get notified
Receive notifications for new and updated recalls and alerts by category.