The Recall Desk

FDA (Devices) recall action 96611

Baxter Healthcare Corporation recalled 2 products on 2025-05-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-05-21
Critical
0
Units
9,055

Why these products were recalled

A cybersecurity vulnerability was discovered through internal testing.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2025-05-21

    Welch Allyn Life2000 Ventilation System Recalled for Cybersecurity Vulnerability

    Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. The recall affects 4,881 units distributed worldwide.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2025-05-21

    Welch Allyn Life2000 Compressor recalled for cybersecurity vulnerability

    Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.

    Product
    Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
    Category
    Distribution
    0 states