Wilson-Cook Medical Inc. recalls Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemost…

Recall date

August 29, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0036-2025

FDA classification

Class II

Brand / firm

Wilson-Cook Medical Inc.

Sold / distributed

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finl…

Why it was recalled

Specific lots of product have been manufactured with nonconforming raw materials.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.