Reusable Patient Return Electrode Recalled Due to Burn Risk
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
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 recall with identified burn injury risk. The agency's Class I classification establishes a minimum severity score of 4 per the rubric, and the documented risk of patient burns justifies this rating.
Plain-English summary
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes (Model 0835) manufactured by Megadyne Medical Products, Inc. have been recalled by the FDA. Approximately 1,463 units have been distributed nationwide and internationally.
The recall is due to an identified risk of patient burns associated with use of the product. The FDA has classified this as a Class I recall. To mitigate this risk, use of these electrodes should be limited to patients aged 12 or older.
Healthcare facilities and medical providers currently using these electrodes should take immediate action to restrict their use to patients aged 12 and older. Users are advised to review manufacturer guidance and the FDA recall notice for additional information.
The recalled product
- Product
- Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord…
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- Affected units
- 1,463
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 (2)
- Product Code: 0835
- UDI-DI: 10614559101872
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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- Severe
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