MEGADYNE MEGA SOFT Patient Return Electrode Recalled for Reported Patient Burns
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode used in electrosurgery due to 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification with reported patient injuries (burns) in surgical procedures. Per FDA criteria, Class I recalls with injury reports warrant a Severe classification.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode (Model No. 0835; UDI-DI: 10614559101872) used during electrosurgery. This recall affects 21,100 units distributed nationwide in the United States.
The recall was initiated due to reports of patient burns occurring in surgical procedures where the device was used.
Patients who underwent surgical procedures using this device and healthcare facilities using this equipment should be aware of this recall. Anyone experiencing complications related to this device should consult their healthcare provider.
For more information, contact Megadyne Medical Products, Inc. directly. Any adverse events or concerns related to this device can be reported to the FDA.
The recalled product
- Product
- MEGADYNE MEGA SOFT Dual Reusable 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. 0835
- UDI-DI: 10614559101872
- 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
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