RegWardenFDA facility compliance records
Company

Megadyne Medical Products, Inc.

8 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2018: 1 recalls; 2023: 3 recalls; 2024: 2 recalls1’131’14’15’16’171’18’19’20’21’223’232’24’25’26
  • Recalls (8)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2024-06-17
    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.
  • Class IOngoing2024-05-08
    Reports of patient burns.
  • Class IOngoing2023-12-08
    Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in b…
  • Class IIOngoing2023-06-15
    An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
  • Class IOngoing2023-06-01
    Firm has received reports of patient burns in surgical procedures where device was used.
  • Class IITerminated2018-05-15
    If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
  • Class IITerminated2014-02-27
    Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the …
  • Class IITerminated2013-08-07
    Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Megadyne Medical Products, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1721194-megadyne-medical-products-inc/

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