Recall of ARROW Radial Artery Catheterization Kits Due to Manufacturing Issue
ARROW INTERNATIONAL, LLC is recalling 675 units of specific Arrow Radial Artery Catheterization Kits after a supplier reported incorrect manufacturing of the liquid adhesive, affecting products distributed nationwide in the U.S.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
ARROW INTERNATIONAL, LLC is recalling certain Arrow Radial Artery Catheterization Kits 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 products include:
- REF ASK-04220-UCL1 with UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 and Batch Number: 33F25J0352
- REF ASK-04020-EUH2 with UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 and Batch Number: 33F25J0869
- REF ASK-04020-FMC with UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 and Batch Number: 33F25J0870
- REF ASK-04020-MMC with UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 and Batch Number: 33F25J0880
A total of 675 units are affected. These products were distributed nationwide in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. The recall number is Z-1911-2026.
What You Should Do
Consumers who have the affected products should follow the initial firm notification, which was issued via letter, for further instructions on how to proceed. 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 involves medical devices that could pose potential health risks due to the manufacturing issue, affecting 675 units distributed across multiple U.S. states. It underscores the importance of quality control in medical products to ensure patient safety.
Source
FDA recall notice: Reference event ID 98618 and recall number Z-1911-2026. Attribution to the U.S. Food and Drug Administration (FDA).
Original source: FDA Official Notice ↗
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