FDA (Devices) recall action 96611
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.
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.
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.
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.