Medtronic HR-ACT Cartridges Recall: Dry Blood on Labels May Cause Contamination
Medtronic recalls HR-ACT cartridges with dry blood on labels. This could lead to contamination during use. Affected units include specific lot numbers. Contact Medtronic for details.
Lower-risk recall
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Contact the company
What happened, in plain English
Medtronic is recalling HR-ACT (High Range Activated Clotting Time) Cartridges with dry blood observed on labels. This could cause contamination during use, though the risk is low and no injuries have been reported. Read more at govinfonow.com/recall/51040-medtronic-hr-act-cartridges-recall-dry-blood-on-labels-may.
Source Summary by GovInfoNow · govinfonow.com/recall/51040-medtronic-hr-act-cartridges-recall-dry-blood-on-labels-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0539-2026
Cite this page
“Medtronic HR-ACT Cartridges Recall: Dry Blood on Labels May Cause Contamination.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51040-medtronic-hr-act-cartridges-recall-dry-blood-on-labels-may. Based on FDA recall #Z-0539-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0539-2026%22&limit=1).
Why it’s dangerous
Dry blood on the external carton label and Instructions for Use (IFU) could lead to contamination during use. This might affect the accuracy of blood clotting tests if the blood residue is not properly cleaned.
Who’s affected
Users of Medtronic HR-ACT Cartridges with the specific lot number 232135734 are affected. Patients using these cartridges for blood clotting tests are most at risk.
How to tell if you have this one
Check for the lot number 232135734 on the cartridge packaging. The product is labeled as HR-ACT (High Range Activated Clotting Time) Cartridges with reference number 402-03.
- Brand
Medtr: a short, human brand name for headings (e.g. "Trsmima")- Category
Medical device
What to do — step by step
Check for Dry Blood
Inspect the external carton label and Instructions for Use (IFU) for dry blood residue.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of Hawaii and New York.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Hawaii, New York.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall indicates a potential for contamination, but no injuries have been reported. The risk is considered low.
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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-0539-2026 (October 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0539-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.