Covidien Bedside SpO2 Monitor: Alarms May Not Be Heard, Risk of Respiratory Failure
Covidien recalls bedside SpO2 monitors that may not alert users to low oxygen levels, risking respiratory failure. Check if your monitor has model numbers listed in the recall notice.
Use caution until it’s fixed
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
Contact the company
What happened, in plain English
Covidien is recalling bedside SpO2 patient monitors that may not sound alarms properly, which could lead to delayed treatment or respiratory failure. This is especially risky for patients with low oxygen levels who need constant monitoring. Read more at govinfonow.com/recall/51982-covidien-bedside-spo2-monitor-alarms-may-not-be-heard-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51982-covidien-bedside-spo2-monitor-alarms-may-not-be-heard-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2151-2025
Cite this page
“Covidien Bedside SpO2 Monitor: Alarms May Not Be Heard, Risk of Respiratory Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/51982-covidien-bedside-spo2-monitor-alarms-may-not-be-heard-risk. Based on FDA recall #Z-2151-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2151-2025%22&limit=1).
Why it’s dangerous
The monitors may not alert users to low oxygen levels, causing treatment delays or respiratory failure. The device's alarm system can be silenced or ignored, which is dangerous for patients who need continuous monitoring.
Who’s affected
Patients using home healthcare or hospital bedside monitors with the listed model numbers are most at risk. Healthcare providers and caregivers who rely on these monitors for patient safety are also affected.
How to tell if you have this one
Check for model numbers like PM100N, 10005941, DLPM100N, or the serial numbers listed in the recall notice. These monitors were sold with specific language and region codes.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Monitor Settings
Ensure alarms are not silenced or reduced in volume, as per the operator's manual.
Verify Model Number
Identify if your monitor has model numbers listed in the recall notice, such as PM100N or 10005941.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2151-2025 (June 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2151-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.