Cochlear Baha 5 Sound Processor Tamper Proof Battery Door… recallZ-0792-2020 · Cochlear Americas Inc. · initiated Dec 18, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cochlear Americas Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was packaged with the Incorrect tamper proof battery door.
FDA root cause category: Packaging process control
What the company is doing
On 12/18/2018, the firm sent a "MEDICAL DEVICE RECALL NOTICE" to affected customers via telephone or email informing them of a packaging error for a specific lot (LOT # COH1253733) Tamper Proof Battery Doors. Customers are instructed to: 1-Examine their inventory and if they should have any of the affected product in their possession to carefully verify that they are the tamper proof version, and if in doubt about the functionality or identity - to scrap the item and to inform the Recalling Firm by filling out and return the Response Form. The Recalling Firm will arrange to send replacement product. 2-If customers receive complaints or queries from their users about "loose battery doors" or similar, to please advise the user to check the functionality according to the Recalling Fir's instructions "Baha 5 User Manual" and to scrap and replace as necessary. 3-To identify customers or users to whom they have distributed battery doors from the affected lot and to provide contact information to the Recalling Firm. The Recalling Firm will make contact, explain the issue, and send replacement product directly to them if necessary. NOTE: If you (the customer) do not have specific records showing with customers may have received affected product, they are to consider providing the Recalling Firm with a list of all customers that received a Baha 5 system between Sept. 1, 2018 and Dec. 18, 2018 so that the Recalling Firm may contact them. For any questions about the product recall customers can contact the Recalling Firm's Quality Department at 303-264-2163.
Recall details
- Recall number
- Z-0792-2020
- Status
- Terminated
- Initiated by the company
- Dec 18, 2018
- Recalling firm
- Cochlear Americas Inc.
- Quantity
- 50 units
- Product code
- LXB
- FDA submissions
- K142907
- Distribution
- Domestic: CA, FL, IL, IN, MA, MO, NY, SD, TN, and TX OUS Regions; Asia Pacific (APAC), and Europe, The Middle East and Africa (EMEA)
Product description
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Code information (models, lots, serial numbers)
Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017Cochlear Limited · Hearing aid, bone conduction1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K142907 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Baha 5 Sound Processor, Blonde 95201Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page