Medical device recalls Moderate risk

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

Recall date
December 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0792-2020
FDA classification
Class II
Brand / firm
Cochlear Americas Inc.
Sold / distributed
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)

Why it was recalled

Product was packaged with the Incorrect tamper proof battery door.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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