# FDA recall Z-1557-2026

> **Covidien LLC** · Class II · device recall initiated 2026-01-30.

## Product

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).

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1557-2026
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-30
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boulder, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1557-2026

## Citation

> AI Analytics. FDA recall Z-1557-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1557-2026. Source: US FDA. Licensed CC0.

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