Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear — Class II medical device recall Z-0988-2014
Terminated recall by Siemens Hearing Instruments, Inc, reported 2014-02-26, distributed nationwide. Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment
| Recall number | Z-0988-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Hearing Instruments, Inc, Piscataway, NJ, United States |
| Recall initiated | 2005-07-01 |
| Classified | 2014-02-18 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2017-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 738 units |
Product
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
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.
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-0988-2014. 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.