Medical device recalls High risk

Baxter Healthcare Corporation recalls Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010…

Recall date
April 7, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1726-2025
FDA classification
Class I
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Worldwide distribution.

Why it was recalled

A cybersecurity vulnerability was discovered through internal testing.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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