Class II — PYRAMES INC
| Recalling firm | PyrAmes Inc |
|---|---|
| Registered facility | PYRAMES INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 |
| Quantity | 35 |
| Distribution | US distribution to states of: MA and CA |
| Initiated | 2025-02-24 |
| Classified | 2025-04-02 |
| Recall number | Z-1508-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PYRAMES INC (Z-1508-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96414/
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