The Recall Desk

Manufacturer

Graphic Controls Acquisition Corporation

6 recalls in our database name Graphic Controls Acquisition Corporation as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2022-04-20

Of the 6 recalls from Graphic Controls Acquisition Corporation 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.

1–6 of 6

  • HighFDA (Devices)·Z-0936-2022·2022-04-20

    Recalled CLARAVUE Pre-wired Electrode Set May Fail During Defibrillation

    Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2022·2022-04-20

    Cardiac electrode fails electrical safety test; defibrillation may not work

    The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2022·2022-04-20

    Pre-wired ECG Electrode Set Fails Defibrillation Voltage Safety Standard

    Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2022·2022-04-20

    CLARAVUE ECG Electrode May Fail to Deliver Effective Defibrillation

    CLARAVUE Pre-wired ECG electrodes may not meet electrical safety standards for defibrillation, potentially delivering an ineffective electrical charge during emergency use. This is a Class II recall affecting devices nationwide.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2022·2022-04-20

    CLARAVUE Pre-wired Electrode fails to meet electrical safety specification

    Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2022·2022-04-20

    ECG Electrode Set Fails Electrical Safety, May Prevent Effective Defibrillation

    Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.

    Product
    CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
    Category
    Medical Device
    Distribution
    Distributed nationwide