Quick Facts at a Glance
- Recall Date
- January 30, 2026
- Hazard Level
- HIGH
- Brand
- Covidien
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Covidien
- Product type
- Remote Patient Monitoring System
- Model numbers
- VSLBASE03P / VITALSYNCSW03 (3.3.1), VSLBASE03P / VITALSYNCSW03 (3.4.0), VSLBASE03P / VITALSYNCSW03 (3.4.1 OUS), VSLBASE03P / VITALSYNCSW03 (3.4.2), VSLBASE04P / VITALSYNCSW04 (4.0.1), VSLBASE04P / VITALSYNCSW04 (4.0.2)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 30, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Covidien LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
HealthCast Vital Sync is a remote patient monitoring system designed to route and store data from bedside monitors to an RPM platform, EMR, and CIS. It supports clinicians in real-time patient data review.
Why This Is Dangerous
A failure in alarm transmission could delay medical staff response to patient status, creating safety risks for monitored patients.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall poses a potential safety risk for patients who rely on real-time alarms to trigger clinical interventions. It may require healthcare facilities to halt use until remediation is confirmed and replacements issued.
Practical Guidance
How to identify if yours is affected
- 1. Verify device CFN: VSLBASE03P or VSLBASE04P and VDI: VITALSYNCSW03/04.
- 4. Review recall letter for remedy details.
Where to find product info
On labeling, packaging, and the recall notice issued by Covidien. The FDA recall page also lists affected models and UDIs.
What timeline to expect
Remedy processing timelines are provided in the recall notification. Consumers should expect 4-8 weeks for refunds or replacements where offered.
If the manufacturer is unresponsive
- Escalate to hospital risk management or infection control.
- File a complaint with the FDA if the company is unresponsive.
How to prevent similar issues
- Verify UDI-DI and model numbers before purchase.
- Register devices with the hospital's asset management system to track recalls.
- Ask manufacturers for recall status during procurement.
Documentation advice
Document all communications, store recall notices, capture photos of labels and UDI-DI codes, retain receipts and purchase records.
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Product Details
Product Numbers: VSLBASE03P / VITALSYNCSW03 and VSLBASE04P / VITALSYNCSW04 UDI-DI codes and serials: - Vital Sync 3.3.1 — 10884521844933 - Vital Sync 3.4.0 — 10884521844940 - Vital Sync 3.4.1 (OUS only) — 10884521847569 - Vital Sync 3.4.2 — 10884521856127 - Vital Sync 4.0.1 — 10884521849358 - Vital Sync 4.0.2 — 10884521856134 Models/CFN: VSLBASE03P / VITALSYNCSW03 Serials correspond to the versioned releases listed above Quantity recalled: 78 systems Distribution: Worldwide, including AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, VA; also Spain.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution with U.S. states listed for recall
- Alarms from bedside monitor not transmitted to remote RPM system
- Class II recall by MedDRA classification (high risk)
- No injuries reported at this time
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Safety Guide
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