Medtronic HR-ACT (High Range Activated Clotting Time… recallZ-0539-2026 · Medtronic Perfusion Systems · initiated Oct 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic issued an Urgent Medical Device Correction notice to its consignees on 10/20/2025 via US mail. The notice explained the issue, potential risk, and requested the following actions be taken: " Please do not open, handle, or use the affected product. " Wear appropriate Personal Protective Equipment (PPE), such as gloves and protective clothing, to review your inventory for the listed lot number. " If you have this lot number in your inventory, place the affected product, including packaging and Instructions for Use, in a clearly marked biohazard bag or container. " Dispose of the biohazard material in accordance with your facility s procedures and all applicable local, state, and federal regulations for biohazardous waste. " Complete the enclosed Customer Confirmation Form and email to [email protected]. " Contact Medtronic Customer Service at 1-800-854-3570, Option 1 then Option 4, and reference this communication to initiate to arrange for credit or replacement product. " Please maintain a copy of this communication in your records. For questions regarding this communication, please contact your Medtronic Field Representative.
Recall details
- Recall number
- Z-0539-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 20, 2025
- Posted by the FDA
- Nov 18, 2025
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 3850 units
- Product code
- JBP
- FDA submissions
- K860122
- Distribution
- US Nationwide distribution in the states of Hawaii and New York.
Product description
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Code information (models, lots, serial numbers)
UDI/DI 20763000433844, Lot Number 232135734
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HR-ACT 402-03Medtronic, Inc. · ACTIVATED WHOLE BLOOD CLOTTING TIME1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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