FDA recall record · openFDA

ARROW INTERNATIONAL, LLC

12 FDA recalls on record (2026) — 12 device. 12 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured 7

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis ki 4

Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured 1

Recalls

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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