Arrow Edge Hemodialysis Catheterization Product Recall

Source: FDA · United States

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ARROW INTERNATIONAL, LLC is recalling 285 units of Arrow Edge Hemodialysis Catheterization Products due to a sheath introducer that may not split as intended.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "high" 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, fda, 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 initiated a voluntary recall of certain Arrow Edge Hemodialysis Catheterization Products because a 16F dual-valved splittable sheath introducer included in the kits may not split as intended. This can result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, or vessel wall injury.

Which Products Are Affected

The recall affects Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I. A total of 285 units are involved. Affected lots include:

  • CS-15242-I / 30801902195280 / 33F23G0536
  • CS-15282-I / 30801902195532 / 33F23C0877, 33F24A0281, 33F24H0041
  • CS-15322-I / 30801902197451 / 33F23G0545 The recall number is Z-2156-2026. Distribution was worldwide, including US nationwide and countries AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW.

What You Should Do

No specific consumer instructions are provided in the recall notice.

Why This Matters

This Class I recall involves a device defect that may cause serious injury during hemodialysis procedures.

Source

FDA recall Z-2156-2026. https://www.fda.gov

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
ARROW INTERNATIONAL, LLC is recalling 285 units of Arrow Edge Hemodialysis Catheterization Products due to a sheath introducer that may not split as intended.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.