MEGADYNE MEGA SOFT Universal Plus Patient Return recall
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Why was MEGADYNE MEGA SOFT Universal Plus Patient Return 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. 0847; UDI-DI: 10614559104842; All Units.
- Product
- MEGADYNE MEGA SOFT Universal Plus 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)