FDAClass IJuly 5, 2023

MEGADYNE MEGA 2000 Patient Return Electrode. used recall

MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery

Why was MEGADYNE MEGA 2000 Patient Return Electrode. used recalled?

Firm has received reports of patient burns in surgical procedures where device was used.

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?

Model No. 0800; UDI-DI: 10614559100936; All Units.

Product
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Recalling firm
Megadyne Medical Products, Inc.
Quantity
21,100 units
Distribution
Distributed US Nationwide.
Recall date
July 5, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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