HR-ACT Cartridges (Medtronic) – External Label Contamination (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
UDI/DI 20763000433844, Lot Number 232135734
Products Sold
UDI/DI 20763000433844, Lot Number 232135734
Medtronic Perfusion Systems is recalling Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 due to 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 Ca. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026