Megadyne MEGA 2000 Patient Return Electrode recalled for burn risk
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now 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 classification requires a minimum severity score of 4. Although no reported injuries are documented in the source, the FDA's Class I determination indicates a serious burn risk to patients under 12 that warrants this classification.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA 2000 Patient Return Electrode (Model 0800), a reusable electrode for adult patients weighing over 25 lbs (11.4 kg), measuring 91 cm long by 51 cm wide. The product has been distributed nationwide and internationally.
The FDA classified this as a Class I recall due to an identified potential risk of patient burns with use of this electrode. All distributed lot numbers are affected.
To mitigate the burn risk, use of this product is now restricted to patients aged 12 or older. Healthcare facilities should review their inventory and implement this age restriction immediately.
The recalled product
- Product
- Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs.…
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- Affected units
- 259
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: 0800
- UDI-DI: 10614559100936
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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Similar recalls
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