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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

Radiometer ABL90 FLEX and FLEX PLUS Analyzers Recalled for Software Freezing

Agency Publication Date: April 23, 2025
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Summary

Radiometer Medical ApS has recalled 6,275 ABL90 FLEX and ABL90 FLEX PLUS blood gas analyzers because the devices can unexpectedly freeze while measuring a medical sample. This defect occurs on analyzers running Windows 10 software versions 1.0 and 1.1. Although the software is designed to automatically restart after a freeze, any medical sample currently being processed will be lost, which can lead to critical delays in patient testing.

Risk

A software freeze during a sample measurement causes the analyzer to stop operating and lose the current patient sample. This results in the loss of medical data and testing delays, which can interfere with timely patient care and clinical decision-making.

What You Should Do

  1. This recall involves Radiometer ABL90 FLEX (Model 393-090) and ABL90 FLEX PLUS (Model 393-092) analyzers running Windows 10 software versions RWIN10 1.0 or RWIN10 1.1.
  2. Check your device model number and serial number to identify if your analyzer is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product for patient testing until the software issue is addressed.
  4. Contact Radiometer Medical or your authorized distributor to coordinate a software update, repair, or further corrective actions.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

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

Affected Products

Product: Radiometer ABL90 FLEX Analyzer
Variants: Portable blood gas analyzer
Model / REF:
393-090
Serial Numbers:
090R0643N002
090R0749N001
090R0757N002
090R0757N004
090R0861N018
090R0874N009
090R0874N011
090R0874N012
090R0892N012
090R0897N023
090R0902N025
090R0943N010
090R0965N003
090R0965N007
090R0965N009
UDI:
05700693930909

Recall #: Z-1659-2025. Analyzers running Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1.

Product: Radiometer ABL90 FLEX PLUS Analyzer
Variants: Portable blood gas analyzer
Model / REF:
393-092
Serial Numbers (1763):
092R0150N001
092R0173N047
092R0173N049
092R0177N055
092R0180N011
092R0180N014
092R0180N025
092R0180N027
092R0185N022
092R0185N024
092R0185N025
092R0185N026
092R0187N016
092R0187N019
092R0187N021
092R0187N026
092R0187N027
092R0188N022
092R0188N024
092R0188N025
092R0188N026
092R0188N027
092R0188N028
092R0188N029
092R0188N033
092R0191N002
092R0195N034
092R0197N026
092R0197N028
092R0197N031
092R0198N005
092R0198N006
092R0198N008
092R0198N009
092R0198N014
092R0198N019
092R0198N027
092R0198N031
092R0200N041
092R0201N001
092R0201N003
092R0201N004
092R0201N006
092R0201N008
092R0204N035
092R0204N036
092R0214N011
092R0214N012
092R0214N013
092R0216N003
UDI:
05700693930923

Recall #: Z-1659-2025. Analyzers running Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96515
Status: Active
Manufacturer: Radiometer Medical ApS
Sold By: Radiometer Medical authorized distributors; hospital supply channels
Manufactured In: Denmark
Units Affected: 6275 analyzers
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, 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.