PYRAMES INC recalls Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

Recall date

February 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1508-2025

FDA classification

Class II

Brand / firm

PYRAMES INC

Sold / distributed

US distribution to states of: MA and CA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007