FDAClass IIApril 24, 2019

Diego Elite Turbinate Blades:Bipolar Blade recall

Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

Why was Diego Elite Turbinate Blades:Bipolar Blade recalled?

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

All lot numbers

Product
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Recalling firm
Gyrus ACMI, Inc.
Quantity
502 OUS
Distribution
Nationwide Foreign: Germany,Japan, Singapore
Recall date
April 24, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls