Class II
Medical Device Recall: Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
PYRAMES INC · February 24, 2025
Reason for Recall
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
Distribution
US distribution to states of: MA and CA
States Affected
CA, MA
Quantity Affected
35
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1508-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.