Z-1920-2024Class I

MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients...

Name: Z-1920-2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients...
Creator: Megadyne Medical Products, Inc.
Published: 2024-05-08
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2024-05-08 / Open, Classified / root cause: design

FDA source

Megadyne Medical Products, Inc. began a recall of MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm... on 2024-05-08. FDA classified it as Class I and gives the reason as "Reports of patient burns". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1920-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-08
Posted: 2024-06-06
Recalling firm: Megadyne Medical Products, Inc
Product: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Reports of patient burns.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were mailed an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notification, dated 5/8/24. The notification instructs consignees to examine their inventory to identify affected devices, quarantine any on-hand devices subject to the recall with a copy of the recall notice, and communicate the recall notification to all those in consignee facilities that should be informed and those facilities to which product was further distributed. Consignees are asked to return a completed Business Reply Form by email to [email protected] or by fax at 800-978-9467. All devices subject to this recall are to be returned immediately; for credit reimbursement customers must return product no later than 8/31/2024. To return product, consignees are to include a photocopy of the completed Business Reply Form in the box with returned devices and affix the pre-paid authorized shipping label on product. Extra shipping labels may be obtained by calling 888-912-7090. Consignees with any questions can contact Ethicon Resource Department at 1-877-384-4266 from 8:00 AM to 5:00 PM EST from Monday through Friday.
Quantity in commerce: 1270
Distribution: Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
Product codes and lots: Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1920-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1920-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-06

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)