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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Covidien Nellcor Bedside Monitoring Systems Recalled for Alarm Failure

Agency Publication Date: July 21, 2025
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Summary

Covidien is recalling approximately 264,790 Nellcor Bedside SpO2 Patient Monitoring Systems because the device's alarms may not be heard or recognized by caregivers. These systems are used to monitor oxygen levels in patients, and a failure to hear an alarm can lead to significant delays in treatment. This recall affects various models used in both clinical and home settings worldwide.

Risk

If an alarm is not heard or recognized, medical staff or caregivers may not respond to low oxygen levels in time, potentially leading to respiratory failure, heart rhythm problems (arrhythmia), or other serious health complications.

What You Should Do

  1. This recall involves Covidien Nellcor Bedside SpO2 Patient Monitoring Systems with various model and part numbers, including PM100N, 10005941, and DLPM100N. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately.
  3. Contact Covidien or your medical equipment distributor to arrange for the return, replacement, or correction of your monitoring system.
  4. Review the operator's manual to ensure patient safety: never silence or decrease alarm volume below audible levels, and ensure the monitor is set to 'Homecare Mode' if used outside of a hospital or professional setting.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have further questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Covidien Nellcor Bedside SpO2 Patient Monitoring System
Model / REF (56):
PM100N
10005941
DLPM100N
DL10005941
DSPM100N
10005941-SG
DS10005941
10005941J
10005941JP
10005941JPN
PM100NKIT
PM100NKITCHDE
PM100NKITCHFR
PM100NKITDA
PM100NKITDE-2
PM100NKITES
PM100NKITFI
PM100NKITFR
PM100NKIT-FR
PM100NKITIT
PM100NKIT-NL
PM100NKITNO
PM100NKITPT
PM100NKITSV
PM100NKITUK
PM100N-10
PM100N-2XMAXN
PM100N-2XMAXN-CC
PM100N-3DYS-CC
PM100N-DYS
PM100N-HC
PM100N-MAXN
PM100N-MAXN-CC
PM100N-OXIAN-CC
BNPULSOKSYMETR
BEDSIDESP2KIT2
NELLSPO2
ROEBEDSIDEKIT
BEDSIDESP2PT2
BEDSIDESP2NO2
BEDSIDESP2PL2
BEDSIDESP2NL2
BEDSIDESP2KITNM
BEDSIDESP2K2UK
BEDSIDESP2K2IT
BEDSIDESP2K2FR
BEDSIDESP2K2-2
BEDSIDEKITISR
BNINHLLCODE
BNINNEL100A
Serial Numbers:
All serial numbers
UDI:
10884521196728
10884521163454
10884521527607
10884521173293
10884521171534
884521512019
884521188689
A8845211634501

Affected units include various Instruction for Use (IFU) part numbers PT00156589 through PT00156676 across multiple languages including English, Spanish, French, German, Arabic, Chinese, and others.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96862
Status: Active
Manufacturer: Covidien
Sold By: Authorized Medical Distributors; Direct Sales from Covidien
Manufactured In: United States
Units Affected: 264,790
Distributed To: Mississippi, Texas, Florida, South Carolina, Virginia, Arizona, Pennsylvania, Minnesota, Ohio, California, Michigan, Colorado, Kansas, Indiana, Illinois, Tennessee, Missouri, Iowa, Oklahoma, Wisconsin, Alaska, New York, Maryland, Alabama, West Virginia, Georgia, North Carolina, Arkansas, Washington, South Dakota, Kentucky, Delaware, New Jersey, Utah, Nevada, Massachusetts, Montana, Guam, Nebraska, Louisiana, Hawaii, Oregon, Rhode Island, New Hampshire, North Dakota, New Mexico, Maine, Connecticut, District of Columbia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.