Boppli: Bedside Device Kit — Class II medical device recall Z-1508-2025
Ongoing recall by PYRAMES INC, reported 2025-04-09, distributed in CA, MA. Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, ma
| Recall number | Z-1508-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PYRAMES INC, Cupertino, CA, United States |
| Recall initiated | 2025-02-24 |
| Classified | 2025-04-02 |
| Reported by FDA | 2025-04-09 |
| Distributed | CA, MA |
| Quantity | 35 |
| UPC / GTIN / UDI-DI | 10860007282901, 10860007282925 |
| Lot numbers | 23103002, 24040302, 24111301 |
| Model numbers | 51-0007, 54-0002 |
Product
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1508-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.