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All product recalls associated with Graphic Controls Acquisition Corporation.
Total Recalls
74
Past Year
1
Class I (Serious)
6
Most Recent
Mar 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Undeclared Egg Allergen
This recall involves dormakaba Delayed Egress Locks with model number DE8310 found on the inside of the wiring cavity cover plate. These locks detect when pressure is applied to a door and are set with a release delay of 15 or 30 seconds. The recalled locks include an internal or external alarm sounder, key switch for reset and override, and a building code sign for single out swinging doors. Delayed egress locks are typically used on perimeter exit doors and internal fire doors to discourage or delay unauthorized exit while providing a safe means of escape during a fire or other catastrophic emergency.