Cochlear Baha 5 Sound Processor Battery Door Recall
Cochlear Americas Inc. is recalling 50 units of Baha 5 Sound Processor Tamper Proof Battery Doors packaged with the incorrect component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging error involving an incorrect component without reporting any illnesses, injuries, or specific functional hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cochlear Americas Inc. is recalling 50 units of the Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.). The recall was initiated because the product was packaged with the incorrect tamper proof battery door.
The affected units are identified by Part Number P1129017, UDI Number 09321502041096, and Lot Number COH1253733. These products were distributed domestically in California, Florida, Illinois, Indiana, Massachusetts, Missouri, New York, South Dakota, Tennessee, and Texas, as well as in the Asia Pacific (APAC) and Europe, The Middle East and Africa (EMEA) regions.
Consumers who have these specific battery doors should contact Cochlear Americas Inc. for further instructions. The source text does not specify a particular action for consumers beyond the recall notice itself.
The recalled product
- Product
- Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
- Manufacturer
- Cochlear Americas Inc.
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733
Distribution
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