MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode — Class I medical device recall Z-2001-2023
Ongoing recall by Megadyne Medical Products, Inc., reported 2023-07-05, distributed nationwide. Firm has received reports of patient burns in surgical procedures where device was used.
| Recall number | Z-2001-2023 |
|---|---|
| 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 | 2023-06-01 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 21,100 units |
| UPC / GTIN / UDI-DI | 10614559104248 |
| Model numbers | 0846 |
Product
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Reason for recall
Firm has received reports of patient burns in surgical procedures where device was used.
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-2001-2023. 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.