Drug recall
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P /…
FDA recall event 98407 · Class II · Covidien LLC
Key facts
| Event ID | 98407 |
|---|---|
| Recall numbers | Z-1557-2026 |
| Recalling firm | Covidien LLC |
| Product type | Devices |
| Products | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 /… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. |
| Initiation date | Jan 30, 2026 |
| Report date | Mar 18, 2026 |
| City | Boulder |
| State | CO |
| Country | United States |
| FEI number | 2936999 |
At a glance
- 1–9 Products in this recall
- None 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: