FDA Device recall Z-1508-2025
Boppli: Bedside Device Kit, REF: 54-0002
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Boppli: Bedside Device Kit, REF: 54-0002 by Pyrames, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1508-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-24 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Pyrames |
| Distribution | CA, MA |
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.
Identifiers
| code_info | Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1508-2025%22
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