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Recall

Class I — Megadyne Medical Products, Inc.

Recalling firmMegadyne Medical Products, Inc.
Registered facilityMEGADYNE MEDICAL PRODUCTS, INC. (the firm's only registered facility)
ClassificationClass I
StatusOngoing
ReasonReports of patient burns.
ProductMEGADYNE 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.
Quantity1270
DistributionWorldwide 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.
Initiated2024-05-08
Classified2024-06-06
Recall numberZ-1920-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Megadyne Medical Products, Inc. (Z-1920-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94544/

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