Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return… — Class I medical device recall Z-2250-2024
Ongoing recall by Megadyne Medical Products, Inc., reported 2024-07-10, distributed nationwide. To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient
| Recall number | Z-2250-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Megadyne Medical Products, Inc., Blue Ash, OH, United States |
| Recall initiated | 2024-06-17 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, CA, CN, DE, ES, GB, GR, IN, IT, JP, KR, NL, NO, SA, SG, TH, TR |
| Quantity | 1,463 units |
| UPC / GTIN / UDI-DI | 10614559101872 |
| Model numbers | 0835 |
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, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
Reason for recall
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2250-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.