Z-0792-2020Class II

Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

Name: Z-0792-2020 Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Creator: Cochlear Americas Inc.
Published: 2018-12-18
License: https://open.fda.gov/license/

Cochlear Americas / initiated 2018-12-18 / Terminated / root cause: packaging

FDA source

Cochlear Americas Inc. began a recall of Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) on 2018-12-18. FDA classified it as Class II and gives the reason as "Product was packaged with the Incorrect tamper proof battery door". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0792-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Posted: 2020-01-24
Terminated: 2021-01-28
Recalling firm: Cochlear Americas
Product: Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Product code: LXB Hearing Aid, Bone Conduction
Reason for recall: Product was packaged with the Incorrect tamper proof battery door.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 50 units
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 codes and lots: Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0792-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0792-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-09

Product code LXB

K142907Class IIBaha 5 Sound ProcessorCochlear Americas / cleared 2015-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)