Recall Z-0539-2026 ยท JBP Activated Whole Blood Clotting Time
Medtronic Perfusion Systems
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
| Date | Nov 18, 2025 (initiated Oct 20, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 3850 units |
| Distribution | US Nationwide distribution in the states of Hawaii and New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME Medical Device Consultants, Inc., Apr 4, 1986 |