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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
ReasonFirm has received reports of patient burns in surgical procedures where device was used.
ProductMEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Quantity21,100 units
DistributionDistributed US Nationwide.
Initiated2023-06-01
Classified2023-06-29
Recall numberZ-1998-2023
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-1998-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92409/

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