The Recall Desk

Manufacturer

GN Otometrics

2 recalls in our database name GN Otometrics as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-10-30

Of the 2 recalls from GN Otometrics 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.

1–2 of 2

  • HighFDA (Devices)·Z-0170-2020·2019-10-30

    GN Otometrics Recalls ICS CHARTR EP 200 Due to Electrical Shock Risk

    GN Otometrics is recalling 3,071 ICS CHARTR EP 200 units because undergrounded electrical surfaces may cause electrical shock to patients or healthcare professionals.

    Product
    The ICS CHARTR EP 200
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-2553-2019·2019-10-02

    GN Otometrics Recalls Gold Cup and Snap Leadwires Due to Conductor Defect

    GN Otometrics is recalling Gold Cup and Snap Leadwires because the electrode lead connector has a protruding conductor beyond the insulation.

    Product
    Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green;
    Category
    Medical Device
    Distribution
    Distributed nationwide