FDAJanuary 30, 2026device
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 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product N...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
covidien
UPCs
108845218449331088452184494010884521847569108845218561271088452184935810884521856134
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACovidien Mon-a-Therm General Purpose Temperature Probe REF: 900442026-04-23
- FDACovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 900502026-04-23
- FDACovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 900422026-04-23
- FDACOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, L...2026-04-15
- FDACovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;2026-04-15
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;2025-09-25
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;2025-09-25
- FDACovidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN2025-06-23
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