Mi1250 SYNCHRONY 2 — Class II medical device recall Z-2356-2024
Ongoing recall by MED-EL Elektromedizinische Gereate, Gmbh, reported 2024-07-24, distributed in NC. A small number of devices may have a higher probability of a crack within the internal electronics substrate w
| Recall number | Z-2356-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MED-EL Elektromedizinische Gereate, Gmbh, Innsbruck, Austria |
| Recall initiated | 2024-04-18 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Distributed | NC |
| Quantity | 7 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 09008737395414, 09008737395452, 09008737395476 |
| Serial numbers | 859106, 860731, 860757, 860772, 860782, 863380, 863386 |
Product
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Reason for recall
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
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-2356-2024. 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.