Product Code 0845 — Class I medical device recall Z-0597-2024
Ongoing recall by Megadyne Medical Products, Inc., reported 2024-01-03, distributed nationwide. Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports
| Recall number | Z-0597-2024 |
|---|---|
| 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 | 2023-12-08 |
| Classified | 2023-12-26 |
| Reported by FDA | 2024-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IT, JO, JP, KR, KW, LB, MA, MY, NL, NO, PH, PL, PT, QA, RO, SA, SE, SG, SK, TH, TR, TW, VN, ZA |
| Quantity | 9,587 units |
| UPC / GTIN / UDI-DI | 10614559103906 |
Product
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Reason for recall
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
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-0597-2024. 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.