Recall database

Activated Whole Blood Clotting Time recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0880-2026

Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

Activated Whole Blood Clotting Time
Packaging process control

Accriva Diagnostics, I…CADec 10, 2025

Class IIOngoingZ-0539-2026

Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges)

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.

Activated Whole Blood Clotting Time
Under Investigation by firm

Medtronic Perfusion Sy…MNNov 26, 2025