RegWardenFDA facility compliance records
Recall

Class II — Cochlear Americas Inc.

Recalling firmCOCHLEAR AMERICAS
Registered facilityView this company's 7 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonProduct was packaged with the Incorrect tamper proof battery door.
ProductCochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Quantity50 units
DistributionDomestic: CA, FL, IL, IN, MA, MO, NY, SD, TN, and TX OUS Regions; Asia Pacific (APAC), and Europe, The Middle East and Africa (EMEA)
Initiated2018-12-18
Classified2020-01-09
Terminated2021-01-28
Recall numberZ-0792-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Cochlear Americas Inc. (Z-0792-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83970/

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