Arrow Cannon II Plus Hemodialysis Catheter Recall
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 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 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, MedicalDevices.
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 ↗
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 (1,598 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.