Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
Center Valley, PA, US · Updated 9/29/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Center Valley, PA, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Center Valley, PA, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Updated 9/18/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Updated 9/18/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Center Valley, PA, US · Updated 9/18/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Updated 9/18/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Updated 9/18/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Center Valley, PA, US · Updated 8/26/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference