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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/Diagnostic Equipment

AVOXimeter 1000E Oximeter Recalled for Incorrect Patient Results

Agency Publication Date: October 31, 2024
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Summary

Accriva Diagnostics, Inc. has recalled one AVOXimeter 1000E bedside whole blood oximeter (Serial Number 6824). The recall was issued because the calibration values used for the device were found to be higher than normal, which can cause the instrument to display oxygen levels that are higher than the patient's actual levels. No incidents or injuries have been reported to date regarding this issue.

Risk

Incorrectly high oxygen readings can lead to patient care mismanagement, as healthcare providers may not realize a patient requires medical intervention for low oxygen levels. This failure to treat low oxygen could lead to serious health complications.

What You Should Do

  1. This recall affects the AVOXimeter 1000E bedside whole blood oximeter (Product Number AVOX1000E) with Serial Number 6824 and UDI-DI 10711234530023.
  2. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  3. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer-coordinated return or correction.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: AVOXimeter 1000E
Model / REF:
AVOX1000E
Serial Numbers:
6824
UDI:
10711234530023

Battery-operated bedside whole blood oximeter.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95497
Status: Resolved
Manufacturer: Accriva Diagnostics, Inc.
Manufactured In: United States
Units Affected: 1
Distributed To: Arizona

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.