MEGADYNE MEGA SOFT Pediatric Patient Return Electrode — Class I medical device recall Z-1920-2024
Ongoing recall by Megadyne Medical Products, Inc., reported 2024-06-12, distributed nationwide. Reports of patient burns.
| Recall number | Z-1920-2024 |
|---|---|
| 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 | 2024-05-08 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CL, CZ, DE, ES, FR, GB, GR, HK, IE, IN, IT, JP, KR, NL, NO, PL, SA, SG, TH, ZA |
| Quantity | 1,270 |
| UPC / GTIN / UDI-DI | 10614559103395 |
| Model numbers | 0840 |
Product
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Reason for recall
Reports of patient burns.
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-1920-2024. 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.