The Recall Desk

Manufacturer

Cochlear Americas Inc.

3 recalls in our database name Cochlear Americas Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2020-01-15

Of the 3 recalls from Cochlear Americas Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Devices)·Z-0792-2020·2020-01-15

    Cochlear Baha 5 Sound Processor Battery Door Recall

    Cochlear Americas Inc. is recalling 50 units of Baha 5 Sound Processor Tamper Proof Battery Doors packaged with the incorrect component.

    Product
    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2155-2015·2015-07-29

    Cochlear Nucleus Sterile Silicone Template Recalled for Expiration

    Cochlear Americas is recalling 26 units of Nucleus Sterile Silicone Templates because expired product was distributed to specific US states.

    Product
    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2014·2014-06-11

    Cochlear Baha Soft Tissue Gauge Recalled for Metal Surface Imperfections

    Cochlear Americas Inc. is recalling 288 Baha Soft Tissue Gauges due to manufacturing imperfections that could leave residual metal on patient skin.

    Product
    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide