HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product... recall (Covidien LLC)
Medical deviceClass IIOngoing
Summary: Covidien LLC is recalling 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 Pr. Reason: 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 is being recalled
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 Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain. (states named: Alaska, Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Virginia)
How to tell if yours is affected
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933 Serial Number: Vital Sync 3.3.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521844940 Serial Number: Vital Sync 3.4.0 CFN: VSLBASE03P / VITALSYNCSW03 (OUS only) UDI-DI (GTIN): 10884521847569 Serial Number: Vital Sync 3.4.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521856127 Serial Number: Vital Sync 3.4.2 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521849358 Serial Number: Vital Sync 4.0.1 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521856134 Serial Number: Vital Sync 4.0.2
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1557-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 30, 2026 |
| Reported | March 18, 2026 |
| Company | Covidien LLC |
| Company location | Boulder, CO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 78 systems |
More recalls from Covidien LLC · all medical device recalls · recalls from January 2026