Drug recall
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
FDA recall event 96414 · Class II · PYRAMES INC
Key facts
| Event ID | 96414 |
|---|---|
| Recall numbers | Z-1508-2025 |
| Recalling firm | PYRAMES INC |
| Product type | Devices |
| Products | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 24, 2025 |
| Report date | Apr 9, 2025 |
| City | Cupertino |
| State | CA |
| Country | United States |
| FEI number | 3014466900 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: