---
title: "Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 — FDA record Z-1508-2025 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-1508-2025-boppli-bedside-device-kit-ref-54-0002-sensor-band-ref-51-0007/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1508-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [California](https://isitonrecall.com/state/california/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1508-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [PYRAMES INC records](https://isitonrecall.com/brand/pyrames-inc/)