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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

Masimo Corporation: Rad-G Pulse Oximeters Recalled for Unexpected Power Cycles

Agency Publication Date: April 12, 2024
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Summary

Masimo Corporation is recalling approximately 27,209 Rad-G Pulse Oximeters because the devices may unexpectedly power off and on automatically. This defect results in a temporary loss of patient monitoring, which could be critical for those relying on constant oxygen saturation and heart rate data. These handheld devices, including models with temperature sensors and standard patient cables, are used in both professional healthcare settings and home environments. Consumers should contact their healthcare provider or Masimo for further guidance on maintaining continuous patient safety.

Risk

If the oximeter shuts down and restarts unexpectedly, healthcare providers or caregivers may experience a gap in patient data and missed alarms. This loss of monitoring could lead to unrecognized respiratory distress or delayed medical intervention for patients in critical condition.

What You Should Do

  1. Identify if your device is affected by checking the reference number (REF) on the product label. Affected models include REF 9210, 9847, 9849, and 9895.
  2. Verify your device's unique identifier by matching the serial number and UDI on the device against the affected list. For example, check for UDI (01)00843997008013 (REF 9210), (01)00843997013284 (REF 9847), (01)00843997000666 (REF 9849), or (01)00843997013789 (REF 9895).
  3. If your device is part of the recall, immediately contact your healthcare provider to discuss alternative monitoring methods or to ensure appropriate backup monitoring is available.
  4. Contact Masimo Corporation at 1-888-463-6332 or visit their website at www.masimo.com for specific instructions regarding device repair, replacement, or updates.
  5. Follow any guidance provided in the official recall letter sent by Masimo to ensure your device is functioning correctly according to professional medical standards.
  6. For additional questions or to report incidents, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit the FDA medical device recall website.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare and Manufacturer Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Masimo Rad-G Pulse Oximeter with temperature (W/Sensor)
Model / REF:
REF:9210
Lot Numbers:
UDI: (01)00843997008013
Serial Numbers: 6000083855 to 6000084061 (inclusive of various numbers in range)
Product: Masimo Rad-G Pulse Oximeter (W/Sensor)
Model / REF:
REF:9847
Lot Numbers:
UDI: (01)00843997013284
Serial Numbers: 6000062119 to 6000092763 (inclusive of various numbers in range)
Product: Masimo Rad-G Pulse Oximeter (W/Patient Cable)
Model / REF:
REF:9849
Lot Numbers:
UDI: (01)00843997000666
Serial Numbers: 6000063773 to 6000093676 (inclusive of various numbers in range)
Product: Masimo Rad-G Pulse Oximeter (W/Patient Cable)
Model / REF:
REF:9895
Lot Numbers:
UDI: (01)00843997013789
Serial Numbers: 6000083849 to 6000084309 (inclusive of various numbers in range)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94170
Status: Active
Manufacturer: Masimo Corporation
Sold By: Authorized medical distributors; Specialty healthcare retailers
Manufactured In: United States
Units Affected: 4 products (443 units; 21,723 units; 4978 units; 65)
Distributed To: Nationwide
Agency Last Updated: September 25, 2024

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.

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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.