MEDITECH Expanse Laboratory — Class II medical device recall Z-2569-2025
Ongoing recall by Medical Information Technology, Inc., reported 2025-09-24, distributed nationwide. Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or qu
| Recall number | Z-2569-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Information Technology, Inc., Canton, MA, United States |
| Recall initiated | 2025-02-05 |
| Classified | 2025-09-16 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IE |
| Quantity | 148 units |
| UPC / GTIN / UDI-DI | 00863529000155 |
Product
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Reason for recall
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2569-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.