Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or…
Tempe, AZ, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Reusable access port system may crack or seperate during use.
Tempe, AZ, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Reusable access port system may crack or seperate during use.
Tempe, AZ, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Reusable access port system may crack or seperate during use.
Tempe, AZ, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Reusable access port system may crack or seperate during use.
Tempe, AZ, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Reusable access port system may crack or seperate during use.
Tempe, AZ, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
Reusable access port system may crack or seperate during use.
Tempe, AZ, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference