Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Draeger Infinity Acute Care System Monitoring Solution Recalled by Draeger Medical Systems, Inc. Due to After a test in which a low SpO2...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Draeger Medical Systems, Inc. directly.
Affected Products
Draeger Infinity Acute Care System Monitoring Solution
Quantity: 439
Why Was This Recalled?
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
Where Was This Sold?
This product was distributed to 8 states: CA, IL, IN, MA, NH, NY, OK, TX
About Draeger Medical Systems, Inc.
Draeger Medical Systems, Inc. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report