Recall of ARROW Radial Artery Catheterization Kits 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 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 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, cpsc, Devices.
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 ↗
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 (1,753 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.