PYRAMES INC: Medical Device Recall in 2025 - (Recall #: Z-1508-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 24, 2025

Date Posted: April 9, 2025

Recall Number: Z-1508-2025

Event ID: 96414

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.

Status: Ongoing

Product Quantity: 35

Code Information:

Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301

Distribution Pattern:

US distribution to states of: MA and CA

Voluntary or Mandated:

Voluntary: Firm initiated