FDAClass II · Medical device · Recalled April 29, 2026

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code recall — ARROW INTERNATIONAL, LLC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1910-2026
Brand: ARROW INTERNATIONAL
Classification: Class II
Units affected: 85
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code

Companies & origin

Recalling firm location: Morrisville, NC, United States
Firm address: 3015 Carrington Mill Blvd, N/A, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots: Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347
Distribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Firm notified the public via: Letter
FDA event ID: 98618
Recall initiated: March 11, 2026
FDA classified: April 22, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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