FDAClass II · Medical device · Recalled April 29, 2026

PERCUTANEOUS SHEATH INTRODUCER with 7 recall — ARROW INTERNATIONAL, LLC

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

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1912-2026
Brand: ARROW INTERNATIONAL
Classification: Class II
Units affected: 115
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

Affected products

PERCUTANEOUS SHEATH INTRODUCER with 7

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-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130
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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