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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 Vet
Medical Devices/Monitoring Devices

Masimo Rad-G Pulse Oximeters Recalled for Unexpected Power Loss

Agency Publication Date: April 22, 2024
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Summary

Masimo Corporation is recalling 518 Rad-G and Rad-G Refurbished Pulse Oximeters because they may automatically power off and on without warning. This defect results in a loss of continuous patient monitoring, which is critical for tracking oxygen levels. The recall affects both new and refurbished units distributed across the United States and multiple international countries.

Risk

The device can unexpectedly shut down and restart, causing an interruption in monitoring. If a patient's oxygen levels drop during this loss of monitoring, healthcare providers may not be alerted, potentially leading to serious health complications or delayed treatment.

What You Should Do

  1. Identify if you have an affected Masimo Rad-G or Rad-G Refurbished Pulse Oximeter by checking the serial number and UDI on the device label.
  2. Check your device against the following identifiers: Rad-G Refurbished (REF: 29097, UDI: 0100843997016179) or Rad-G Pulse Oximeter (REF: 99025, UDI: 0100843997016421). See the Affected Products section below for the full list of affected codes.
  3. If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Masimo Rad-G Refurbished, Pulse Oximeter
Variants: Rx Only
Model:
29097
Serial Numbers:
6000073705
6000075925
6000068243
6000067136
6000072521
6000071670
6000068015
6000068175
6000068157
UDI:
0100843997016179

Recall #: V-0050-2024

Product: Masimo Rad-G Pulse Oximeter
Variants: Rx Only
Model:
99025
Serial Numbers (509):
6000068868
6000069242
6000069243
6000069681
6000069682
6000069686
6000069082
6000069478
6000069714
6000069694
6000069110
6000069705
6000067913
6000068435
6000068587
6000067887
6000068287
6000068328
6000068586
6000068279
6000068590
6000069069
6000069729
6000070103
6000067947
6000067480
6000069690
6000069079
6000070097
6000069383
6000069324
6000069764
6000070049
6000069841
6000069289
6000069589
6000069767
6000069813
6000069849
6000070026
6000069285
6000069579
6000069955
6000069268
6000070033
6000070032
6000069267
6000069275
6000069969
6000069926
UDI:
0100843997016421

Recall #: V-0051-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94391
Status: Active
Manufacturer: Masimo Corporation
Sold By: Authorized Medical Distributors; Direct Sales
Manufactured In: United States
Units Affected: 2 products (9 units; 509 units)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming
Agency Last Updated: May 7, 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.

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