Recall archive / FDA company announcement
Megadyne: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes — FDA announcement Feb 29, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Feb 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
- Reason
- Limit use to patients aged 12 years or older.
- Classification
- Not supplied
- Recalling firm
- Megadyne Medical Products, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- e1f497ce46009c8d
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Name | Product Code | UDI-DI; MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode | 0845 | 10614559103906; MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode | 0846 | 10614559104248; MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode | 0847 | 10614559104842; MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode | 0848 | 10614559104859 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Product Name | Product Code | UDI-DI |
|---|---|---|
| MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode | 0845 | 10614559103906 |
| MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode | 0846 | 10614559104248 |
| MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode | 0847 | 10614559104842 |
| MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode | 0848 | 10614559104859 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Feb 29, 2024
- Company announcement date
- Feb 29, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.