Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

FDA device recall Z-0539-2026 · posted 2025-11-18 · Open, Classified

Recall details

Recalling firm

Medtronic Perfusion Systems

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.

Action taken

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 RS.CFQFCA@medtronic.com. " 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JBP

Quantity affected

3850 units

Distribution

US Nationwide distribution in the states of Hawaii and New York.

Date initiated

2025-10-20

Date posted

2025-11-18

Location

Brooklyn Park, MN

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