Recall Z-1725-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1725-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-07

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-04-07. It names one FDA 510(k) clearance: K170037. Product: Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.. Reason: A cybersecurity vulnerability was discovered through internal testing..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2025-04-07
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K170037 — Breathe Technologies Life2000 Ventilation SystemBreathe Technologies·cleared 2017-08-11

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 Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.

Reason for recall

A cybersecurity vulnerability was discovered through internal testing.

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