CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Medtronic Hr-act (High Range Activated Clotting Time Cartridges) recalled
Medtronic Perfusion Systems is recalling Medtronic Hr-act (High Range Activated Clotting Time Cartridges), distributed nationwide in the US. The recall was initiated on 20 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0539-2026
- FDA event ID
- 97912
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Oct 2025
- FDA classified
- 18 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2025 | Recall initiated by company | |
| 18 Nov 2025 | Classified by FDA | +29 days |
| 26 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Where it was distributed
US Nationwide distribution in the states of Hawaii and New York.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 20763000433844, Lot Number 232135734
Where was it sold?
US Nationwide distribution in the states of Hawaii and New York.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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