Z-0539-2026Class II

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

Name: Z-0539-2026 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Creator: Medtronic Perfusion Systems
Published: 2025-10-20
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2025-10-20 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Perfusion Systems began a recall of Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 on 2025-10-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0539-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-20
Posted: 2025-11-18
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Product code: JBP Activated Whole Blood Clotting Time
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.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 3850 units
Distribution: US Nationwide distribution in the states of Hawaii and New York.
Product codes and lots: UDI/DI 20763000433844, Lot Number 232135734

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0539-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0539-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-18

Product code JBP

K860122Class IIHemotec Act High Range Activated Clotting TimeMedical Device Consultants, Inc. / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)