Arrow Cannon II Plus Hemodialysis Catheter Recall
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ARROW INTERNATIONAL, LLC is recalling 34,568 Cannon II Plus Hemodialysis Catheters 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, MedicalDevices) 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 Cannon II Plus Hemodialysis Catheters because the 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 Cannon II Plus Hemodialysis Catheter (REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP) and Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer (REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM). A total of 34,568 units are affected. Specific lot numbers are listed under recall number Z-2158-2026. The products were distributed 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
Consumers and healthcare providers should review the recall notice for affected lot numbers and follow any instructions provided by the recalling firm.
Why This Matters
This Class I recall involves devices used in hemodialysis procedures where sheath failure could lead to serious injury risks including bleeding and vessel wall injury.
Source
FDA Recall Z-2158-2026 - ARROW INTERNATIONAL, LLC, Morrisville, NC
Original source: FDA Official Notice ↗
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