Cupertino, CA, United States
PYRAMES INC recalls
1 recall recorded since 2018, most recently on 24 February 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 February 2025
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1508-2025
- Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.