FDAClass IIOctober 5, 2022

Olympus POWERSEAL 5MM recall

Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in…

Why was Olympus POWERSEAL 5MM recalled?

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170

Product
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in…
Recalling firm
Olympus Corporation of the Americas
Quantity
27 units (5/box) US; 83 units(5/box) OUS
Distribution
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Recall date
October 5, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls