Recall Z-1558-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1558-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-24

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-03-24. It names one FDA 510(k) clearance: K171621. Product: Welch Allyn Connex Vital Signs Monitor (CVSM):. Reason: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-03-24
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs MonitorWelch Allyn, Inc.·cleared 2017-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Welch Allyn Connex Vital Signs Monitor (CVSM):

Reason for recall

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.