Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N Recalled by Covidien Due to Bedside SpO2 Patient Monitoring System alarms not heard/recognized,...
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 Covidien directly.
Affected Products
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Quantity: 264,790
Why Was This Recalled?
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien
Covidien has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report