MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Patient Burn Hazard
Megadyne Medical Products is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrodes nationwide due to reports of patient burns during electrosurgical procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall with reported patient burn injuries. Class I classification mandates minimum severity score of 4 per the rubric; reported injuries confirm Severe designation.
Plain-English summary
Megadyne Medical Products, Inc. is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrode units (Model No. 0830) distributed nationwide in the United States.
The device is used as a patient return electrode during electrosurgical procedures. The firm has received reports of patient burns associated with this device during surgical procedures.
The recalled electrodes were distributed nationwide. Healthcare facilities and surgical centers may have received this product.
The FDA has classified this as a Class I recall. For additional information, contact Megadyne Medical Products, Inc. or the FDA.
The recalled product
- Product
- MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
- Manufacturer
- Megadyne Medical Products, Inc.
- Category
- Medical Device — Electrosurgery
- 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. 0830
- UDI-DI: 10614559101797
- 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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