Recall of Arrow Echogenic Introducer Needle Due to Manufacturing Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ARROW INTERNATIONAL, LLC is voluntarily recalling 85 units of Arrow Echogenic Introducer Needle because the liquid adhesive was incorrectly manufactured, as notified by a supplier.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
ARROW INTERNATIONAL, LLC is recalling the Arrow Echogenic Introducer Needle due to a notice from a supplier that the liquid adhesive was incorrectly manufactured. This is a voluntary, firm-initiated recall classified as Class II.
Which Products Are Affected
The affected product is Arrow Echogenic Introducer Needle, REF ASK-04001-BWK2, with UDI code (01)10801902220315(17)261231(11)251210(10)33F25J0347 and Batch Number 33F25J0347. Approximately 85 units are affected, with distribution in the U.S. states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. The recall number is Z-1910-2026.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact ARROW INTERNATIONAL, LLC at their address: 3015 Carrington Mill Blvd, Morrisville, NC 27560-5437, for information on returns or refunds.
Why This Matters
This recall affects medical devices intended for injection or aspiration of fluids, potentially impacting user safety due to the manufacturing issue with the adhesive.
Source
Attribution: FDA Recall Number Z-1910-2026. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,150 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.