Z-2248-2024Class I

Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return...

Name: Z-2248-2024 Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return...
Creator: Megadyne Medical Products, Inc.
Published: 2024-06-17
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2024-06-17 / Open, Classified

FDA source

Megadyne Medical Products, Inc. began a recall of Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software... on 2024-06-17. FDA classified it as Class I and gives the reason as "To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2248-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-06-17
Posted: 2024-07-03
Recalling firm: Megadyne Medical Products, Inc
Product: Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
FDA root cause: Unknown/Undetermined by firm
Action: An URGENT MEDICAL DEVICE CORRECTION letter, dated 6/17/24, was mailed to consignees. Consignees are instructed to share the recall notification with all users of affected devices and confirm their understanding, post a copy of the communication for user awareness, and forward the recall notification to any facility to which product was shipped. The notification reads that Mega Soft and Mega 2000 devices are only to be used for patients 12 years old. The notification also reminds consignees to follow proper cleaning, placement, and setup steps. Consignees are asked to complete and return the provided Business Reply Form by fax to 844-441-2732 or by email to [email protected]. Customers with any questions about the communication can contact Ethicon at 1-877-384-4266 from Monday through Friday from 8:00 AM EST to 5:00 PM EST. UPDATE: Starting in September 2024, the firm communicated to new and existing consignees reiterating the use of affected devices in patients aged 12 years and older. Additionally, the firm's letter informs consignees that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet).
Quantity in commerce: 259 units
Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
Product codes and lots: Product Code: 0800; UDI-DI: 10614559100936; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2248-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2248-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03
Z-2249-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03
Z-2250-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code GEI

K080741Class IIMega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. / cleared 2008-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)