Recall archive / FDA device enforcement
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 — FDA record Z-1508-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
- 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.
- Classification
- Class II
- Recalling firm
- PYRAMES INC
- Quantity
- 35
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1508-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: MA and CA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 9, 2025
- Recall initiation date
- Feb 24, 2025
- Center classification date
- Apr 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.