CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
Siemens Prisma 2K Hearing Aid recalled by Siemens Hearing Instruments
Siemens Hearing Instruments is recalling Siemens Prisma 2K Hearing Aid, distributed nationwide in the US. The recall was initiated on 1 Jul 2005 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-0988-2014
- FDA event ID
- 67241
- Recalling firm
- Siemens Hearing Instruments, Piscataway, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2005
- FDA classified
- 18 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hearing Aids
Timeline
| 1 Jul 2005 | Recall initiated by company | |
| 18 Feb 2014 | Classified by FDA | +3154 days |
| 26 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.
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
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Where it was distributed
USA Nationwide Distribution
Questions about this recall
Why was it recalled?
Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.
Which lots are affected?
Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938
Where was it sold?
USA Nationwide Distribution
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.
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 |