Data Foundry

Medical device recalls 2026

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: — Class II medical device recall Z-1910-2026

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

Recall numberZ-1910-2026
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)
Quantity85
UPC / GTIN / UDI-DI10801902220315
Lot numbers33F25J0347
Model numbersASK-04001-BWK2

Product

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.

Reason for recall

Due to receiving a notice from a supplier that the liquid adhesive were 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-1910-2026. 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.