FDA Medical Device Recalls (openFDA)
Megadyne Medical Products, Inc.: 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.
- Recall number
- Z-1920-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-05-08
- Posted
- 2024-06-06
- Terminated
- not on file
- Reason
- Reports of patient burns.
- 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 ethicon4284@sedgwick.com 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
- 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.
- Lot, serial or model codes
- Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.
- 510(k) numbers
- ["K080741"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1721194
- Firm city
- Blue Ash
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28