Quick Facts at a Glance
- Recall Date
- February 5, 2025
- Hazard Level
- HIGH
- Brand
- Medical Information Technology
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medical Information Technology
- Product type
- Laboratory software/calculator module
- Model numbers
- Software Release: 2.1, 2.2 (using the Web Presentation Layer)
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 5, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medical Information Technology, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
MEDITECH Expanse is a hospital information system platform. The calculator/data processing module helps clinicians process inputs and generate results across laboratories and pathology departments.
Why This Is Dangerous
If multiple keys trigger input at once, the system may remove data from the first field, risking data integrity in screens with multiple fields.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
High risk to data integrity in clinical workflows. Affects patient data accuracy and could delay results.
Practical Guidance
How to identify if yours is affected
- Identify MEDITECH Expanse Laboratory calculator/data processing module in use at your facility.
- Check software release version: 2.1 or 2.2 (Web Presentation Layer).
- Verify UDI 00863529000155 on device labels or documentation.
Where to find product info
Refer to MEDITECH recall instructions and FDA page Z-2569-2025.
What timeline to expect
Remediation timelines vary; follow manufacturer guidance. Expect weeks for instructions and potential software update.
If the manufacturer is unresponsive
- Escalate to MEDITECH corporate support.
- Consult healthcare institution's procurement or biomedical engineering if needed.
How to prevent similar issues
- Implement input validation to prevent multi-key input issues in future software updates.
- Regularly review FDA and CPSC recall databases for software/diagnostic tools.
- Ensure robust data backup and integrity checks in clinical systems.
Documentation advice
Document device model, software version, UDI, dates of recall notification, and communications with MEDITECH. Store correspondence and screenshots.
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Product Details
Product: MEDITECH Expanse Laboratory calculator/data processing module for clinical use. Models include Software Release 2.1 and 2.2 (Web Presentation Layer). UDI: 00863529000155. Quantity: 148 units. Distribution: Worldwide (US nationwide; Britain, Canada, Ireland, United Kingdom). Recall date: 2025-02-05. Status: ACTIVE.
Reported Incidents
No injuries or incidents are reported in the provided data.
Key Facts
- Recall active as of 2025-09-24
- High hazard level
- Software Release: 2.1 and 2.2 (Web Presentation Layer)
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Safety Guide
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