Mega SoftRecalls & reported problems across all models

We found 11 models of Mega Soft by Megadyne Medical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 145 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2018 and Aug 19, 2026 — classified as 86 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (27 reports).

14 FDA recall records name at least one of these models by its device identifier, 14 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Mega Soft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 17, 2024Open, Classified

   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.

   Z-2250-2024 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Jun 17, 2024Open, Classified

   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.

   Z-2249-2024 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

3. May 8, 2024Open, Classified

   Reports of patient burns.

   Z-1920-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Dec 8, 2023Open, Classified

   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 both pediatric and adult patients.

   Z-0600-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Dec 8, 2023Open, Classified

   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 both pediatric and adult patients.

   Z-0599-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Dec 8, 2023Open, Classified

   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 both pediatric and adult patients.

   Z-0598-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Dec 8, 2023Open, Classified

   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 both pediatric and adult patients.

   Z-0597-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jun 1, 2023Open, Classified

   Firm has received reports of patient burns in surgical procedures where device was used.

   Z-2001-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Jun 1, 2023Open, Classified

   Firm has received reports of patient burns in surgical procedures where device was used.

   Z-2000-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. Jun 1, 2023Open, Classified

    Firm has received reports of patient burns in surgical procedures where device was used.

    Z-1999-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Jun 1, 2023Open, Classified

    Firm has received reports of patient burns in surgical procedures where device was used.

    Z-1998-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. Jun 1, 2023Open, Classified

    Firm has received reports of patient burns in surgical procedures where device was used.

    Z-1997-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. Jun 1, 2023Open, Classified

    Firm has received reports of patient burns in surgical procedures where device was used.

    Z-1996-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Jun 1, 2023Open, Classified

    Firm has received reports of patient burns in surgical procedures where device was used.

    Z-1995-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Mega Soft problems

Mega Soft models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mega Soft 0845

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls72 reports
• Mega Soft 0846

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls23 reports
• Mega Soft 0848

  Electrosurgical, cutting & coagulation & accessories
  2 recalls11 reports
• Mega Soft 0847

  Electrosurgical, cutting & coagulation & accessories
  2 recalls10 reports
• Mega Soft 0830

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls9 reports
• Mega Soft 0840

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls5 reports
• Mega Soft 0835

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls4 reports
• Mega Soft M2K07

  Electrosurgical, cutting & coagulation & accessories
  7 reports
• Mega Soft M2K09

  Electrosurgical, cutting & coagulation & accessories
  2 reports
• Mega Soft M2K01

  Electrosurgical, cutting & coagulation & accessories
  1 report
• Mega Soft M2K02

  Electrosurgical, cutting & coagulation & accessories
  1 report

Recent Mega Soft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burn(s)

  MAUDE report 50329900 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a C-Section there was an occurrence of a patient burn during a surgical procedure due to insulation and the presence of the pad under the patient.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50038395 ↗
• InjuryMar 30, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY WERE PERFORMING A PACEMAKER SURGERY ON A PATIENT WHEN A FIRE STARTED, CAUSING BURNS TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 24727750 ↗
• MalfunctionJan 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BURN SUFFERED BY CANINE (BACK, BETWEEN SHOULDER BLADES) DURING TPLO SURGERY BECAUSE OF ASSUMED USE OF MEGA SOFT PAD. VETERINARIAN MENTIONED THAT SHE SUSPECTED BURN IS DUE TO THE USE OF THE MEGA SOFT PAD DURING THE PROCEDURE BECAUSE OF THE PRESENTATION AND LOCATION OF THE BURN AND AWARENESS OF RECALL AND ISSUES WITH THE PAD - BUT COULD NOT CONFIRM OR DISPROVE USE OF THE MEGA SOFT PAD DURING THIS PARTICULAR PROCEDURE. CANINE IS STABLE AND BURN IS BEING TREATED.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225320 ↗
• MalfunctionNov 5, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS SPARKING WITH THE MEGADYNE PAD WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475621 ↗
• MalfunctionNov 5, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS SPARKING WITH THE MEGADYNE PAD WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475604 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NEPHRECTOMY THERE WAS A PATIENT BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22860466 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DOCTOR USED MEGA SOFT UNIVERSAL ELECTRODE AND AFTER THE SURGERY THE DOCTOR OBSERVED THE SKIN GOT SEVERED BURNED IN POSTERIOR SIDE OF PATIENT BODY.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 22742602 ↗
• MalfunctionAug 5, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS SPARKING WITH THEIR MEGADYNE PAD WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719521 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A PAD SITE BURN.

  Patient problems: Blister; Burn(s)

  MAUDE report 21374674 ↗
• MalfunctionFeb 10, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN WHILE USING AN ELECTROCAUTERY PENCIL, THE ELECTRICITY ARCED TO THE SURGEONS HAND HOLDING A LAPAROTOMY SPONGE. THE ARC CAUSED THE SPONGE TO LIGHT ON FIRE AND INITIALLY THE SURGEON THOUGHT HER GLOVE MAY HAVE HAD A HOLE BUT THERE WAS NO INDICATION OF A BURN OR INJURY TO HER FINGER. THE SURGEON BELIEVED THE MEGASOFT PAD TO BE THE CAUSE SO THEY CONTINUED THE CASE USING A STICKY PAD AND HAD NO FURTHER ISSUES. UPON INSPECTION, THE MEGASOFT PAD DID NOT APPEAR TO HAVE ANY DAMAGE, BURNS, OR OTHER ISSUES AND THE PATIENT DID NOT SUFFER ANY INJURIES EITHER. THE SURGERY WAS DELAYED 15 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. FIRE WAS PUT OUT AND A STICKY PAD WAS USED.,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343128 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE THE PATIENT SUFFERED A BURN ON THEIR LOWER LEG POSTERIOR. WHILE THE REP WAS DISCUSSING THE IFU CHANGE AT THE ACCOUNT THE ACCOUNT MENTIONED THIS ISSUE HAPPENED MONTHS AGO.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20684412 ↗
• MalfunctionNov 11, 2024Arcing of Electrodes; Human-Device Interface Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Human-Device Interface Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE FROM A VETERINARY THAT DURING AN OPERATION WITH THE MEGADYNE MAT, THE MAT EXPLODED AND CAUGHT FIRE. SMALL FLASHES ALL OVER THE MAT, WHICH THEN ENDED IN SEVERAL FLAMES. AFTER THE INCIDENT, YOU COULDN'T SEE WHAT HAD HAPPENED ON THE MAT. THE PATIENT WAS A SMALL YORKSHIRE TERRIER (APPROX. 3 KG). HE SUFFERED BURNS TO HIS STOMACH. THE MAT WAS CONNECTED TO AN MEGADYNE GENERATOR EXPIRATION DATE 30.09.2023.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Necrosis; Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 20651317 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HIP SURGERY THE PATIENT GOT BURN WHEN MEGASOFT WAS USED ON THE OPPOSITE SIDE OF THE PATIENT ( PART OF BODY TOUCHES THE TABLE NOT THE SURGICAL AREA). .

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20560236 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PATIENT SUFFERED A THIRD-DEGREE BURN. A SURGICAL INTERVENTION WAS REQUIRED. THE IMPACTED DEVICE WAS USED BY THE SURGEON WHEREAS IT WAS ALREADY EXPIRED (SINCE APRIL 2021).

  Patient problems: Full thickness (Third Degree) Burn; Pain

  MAUDE report 20266062 ↗

Other Megadyne Medical Products, Inc. products

• Mega 20002 models · 14 reports · 2 recalls