Merge Hemo Software 10.2-10.4 Recall: Safety Issue with Lab Interface
Merge Healthcare recalls software versions 10.2, 10.3, and 10.4 due to safety issues when used with HL7 lab interfaces. Affected users should contact the company for updates.
Lower-risk recall
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
Contact the company
What happened, in plain English
Merge Healthcare is recalling software versions 10.2, 10.3, and 10.4 for a safety issue when used with HL7 lab interfaces. This could pose a risk to lab systems if not properly managed. Read more at govinfonow.com/recall/62164-merge-hemo-software-10-2-10-4-recall-safety-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/62164-merge-hemo-software-10-2-10-4-recall-safety-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2387-2021
Cite this page
“Merge Hemo Software 10.2-10.4 Recall: Safety Issue with Lab Interface.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62164-merge-hemo-software-10-2-10-4-recall-safety-issue. Based on FDA recall #Z-2387-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2387-2021%22&limit=1).
Why it’s dangerous
The software versions 9.x and 10.x have a safety issue when combined with HL7 lab interfaces. This could lead to improper lab system communication if not handled correctly.
Who’s affected
Users of Merge Hemo software versions 10.2, 10.3, and 10.4 with HL7 lab interfaces are affected. Lab technicians and healthcare facilities using these versions are most at risk.
How to tell if you have this one
Check for software versions 10.2, 10.3, or 10.4 labeled with the UDI codes provided. These versions were sold with specific dates as listed in the recall notice.
- Brand
Merge Healthcare- Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4- Category
Medical device
What to do — step by step
Contact Merge Healthcare
Reach out to Merge Healthcare directly for guidance on the recall and potential fixes.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the software?
The recall does not require immediate stop use; contact Merge Healthcare for updates.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2387-2021 (July 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2387-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.