MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode Recalled for Patient Burns
Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall, which meets the criteria for Critical severity. This classification reflects that there is a reasonable probability the product will cause serious adverse health consequences, which is supported by reports of patient burns in surgical procedures using the device.
Plain-English summary
Megadyne Medical Products, Inc. is recalling 21,100 units of MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode (Model No. 0847, UDI-DI: 10614559104842) distributed nationwide in the United States. This device is used during electrosurgical procedures.
The recall was initiated because the manufacturer has received reports of patient burns in surgical procedures where the device was used. The FDA has classified this as a Class I recall.
Healthcare facilities and surgical centers that have used or may have unused units of this device should immediately identify the affected units and cease use. Patients who may have been exposed to this device during surgery should consult with their healthcare provider if they experience any unexplained burns or injuries.
The recalled product
- Product
- MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- Affected units
- 21,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 0847
- UDI-DI: 10614559104842
- All Units.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Megadyne Medical Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Megadyne Medical Products, Inc.
See all →- SevereReusable Patient Return Electrode Recalled Due to Burn Risk
FDA (Devices) · 2024-07-10
- SevereMEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Burn Risk
FDA (Devices) · 2024-07-10
- SevereMegadyne MEGA 2000 Patient Return Electrode recalled for burn risk
FDA (Devices) · 2024-07-10
- CriticalPediatric Patient Return Electrode Recalled for Reported Patient Burns
FDA (Devices) · 2024-06-12
- SevereMegadyne Patient Return Electrodes Recalled Due to Serious Burn Risk
FDA (Devices) · 2024-01-03
Same hazard · burn injury
See all →- SevereDREO Recalls DR-HSH015 Space Heaters Due to Fire and Burn Hazards
CPSC · 2026-10-29
- HighQZH.DUAO Children's Pajama Sets Recalled for Burn Hazard
CPSC · 2026-10-29
- Severe
- SevereHAIARA Power Banks Recalled Due to Fire and Burn Hazards
CPSC · 2026-10-29
- SevereWhatever Works Recalls Microwave Grills Due to Fire Hazard
CPSC · 2026-10-29
Similar recalls
- CriticalMEGADYNE MEGA SOFT Return Electrode Recalled Due to Reported Patient Burn Injuries
FDA (Devices) · 2024-01-03
- SevereMegadyne Patient Return Electrodes Recalled Due to Serious Burn Risk
FDA (Devices) · 2024-01-03
- CriticalMegadyne Patient Return Electrode Recalled Due to Serious Burn Injury Reports
FDA (Devices) · 2024-01-03
- CriticalMegadyne MEGA SOFT Return Electrode Recalled for Serious Burn Injuries
FDA (Devices) · 2024-01-03
- CriticalPediatric Patient Return Electrode Recalled for Reported Patient Burns
FDA (Devices) · 2024-06-12
- SevereReusable Patient Return Electrode Recalled Due to Burn Risk
FDA (Devices) · 2024-07-10