Medtronic HR-ACT recall
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Why was Medtronic HR-ACT 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 20763000433844, Lot Number 232135734
- Product
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 3850 units
- Distribution
- US Nationwide distribution in the states of Hawaii and New York.
- Recall date
- November 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)