CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Mi1250 Synchrony recalled by MED-EL Elektromedizinische
Med-el Elektromedizinische Gereate is recalling Mi1250 Synchrony 2, distributed in North Carolina. The recall was initiated on 18 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2356-2024
- FDA event ID
- 94531
- Recalling firm
- Med-el Elektromedizinische Gereate, Innsbruck
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Apr 2024
- FDA classified
- 12 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hearing Aids
Timeline
| 18 Apr 2024 | Recall initiated by company | |
| 12 Jul 2024 | Classified by FDA | +85 days |
| 24 Jul 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Where it was distributed
US, Durham, NC
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386
Where was it sold?
US, Durham, NC
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Med-el Elektromedizinische Gereate
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|---|---|---|---|---|---|
| Device | CLASS II | MED EL Cochlear Implant System, PULSARci100 Standard recalled | Med-el Elektromedizinische Gereate | Packaging Defects | Nationwide |
| Device | CLASS II | MED EL Cochlear Implant System, SONATATIi100 recalled | Med-el Elektromedizinische Gereate | Packaging Defects | Nationwide |
| Device | CLASS II | MED EL Cochlear Implant System, Mi1000 MED EL Concerto recalled | Med-el Elektromedizinische Gereate | Packaging Defects | Nationwide |
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Other Hearing Aids recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | See RES for full list recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Chp Cochlear Supplement Cds recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Device Malfunction | Nationwide |