Medical device recalls Moderate risk

ARROW INTERNATIONAL, LLC recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Thi…

Recall date
March 11, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1910-2026
FDA classification
Class II
Brand / firm
ARROW INTERNATIONAL, LLC
Sold / distributed
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Why it was recalled

Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

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

What was recalled

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

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