Centennial, CO, United States
Cochlear Americas Inc. recalls
1 recall recorded since 2018, most recently on 18 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 December 2018
- Terminated
- 28 January 2021
- Reason
- Product was packaged with the Incorrect tamper proof battery door.
- 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)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0792-2020
- Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.