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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

MEDITECH Expanse Clinical Software Recalled for Data Removal Risk

Agency Publication Date: September 16, 2025
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Summary

Medical Information Technology, Inc. has recalled 148 units of its MEDITECH Expanse software, which includes Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), and Genetics (GEN) modules. This software is a calculator and data processing module used for clinical purposes. The recall affects Software Releases 2.1 and 2.2 that use the Web Presentation Layer. No injuries or incidents have been reported, but the manufacturer initiated this voluntary recall after discovering that clinical data could be accidentally deleted during data entry.

Risk

When a user presses multiple keys simultaneously while entering information, the software may delete data from the first field on screens or questionnaires that have more than one entry field. This could lead to the loss of critical clinical information or patient data during processing.

What You Should Do

  1. This recall affects MEDITECH Expanse software modules for Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), and Genetics (GEN) under Software Releases 2.1 and 2.2.
  2. Identify affected software by checking the release version (2.1 or 2.2) and the Unique Device Identifier (UDI) 00863529000155.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. 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: MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN)
Variants: Software Release 2.1, Software Release 2.2, Web Presentation Layer
UDI:
00863529000155

Calculator/data processing module for clinical use.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97455
Status: Active
Manufacturer: Medical Information Technology, Inc.
Sold By: Direct sales to hospitals; Direct sales to laboratories
Manufactured In: United States
Units Affected: 148 units
Distributed To: Nationwide

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.