Data Foundry

Medical device recalls 2026

ARROW — Class II medical device recall Z-1914-2026

Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-04-29, distributed nationwide. Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Recall numberZ-1914-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmARROW INTERNATIONAL, LLC, Morrisville, NC, United States
Recall initiated2026-03-11
Classified2026-04-22
Reported by FDA2026-04-29
DistributedNationwide (US)
Quantity395
UPC / GTIN / UDI-DI10801902133110, 10801902223668, 10801902223675, 10801902223699
Lot numbers33F25L0140, 33F25L0143, 33F25L0144, 33F25L0145
Model numbersASK-42802-PLH, ASK-42854-MGH, ASK-45703-MGH, ASK-45854-MGH

Product

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1914-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.