FDA recall Z-1508-2025

Product

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

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

Key facts

Status

Ongoing

Initiation date

2025-02-24

Report date

2025-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cupertino, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1508-2025