Arrow International Recalls Arterial Catheterization Kits
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ARROW INTERNATIONAL, LLC is recalling 491,489 units of various arterial line and catheter kits distributed nationwide due to inclusion of recalled drugs with potential sterility issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 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 multiple arterial catheterization kits and sets after a supplier recall of Lidocaine, Bupivacaine, and 0.9% sodium chloride included in the kits. The supplier had quality issues with limited reports of drug ineffectiveness. Compromised sterility of water-based injectable products could lead to serious or life-threatening injuries. This is a Class I recall.
Which Products Are Affected
The recall covers 491,489 units of products including RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; and dozens of additional models such as ASK-00520-JH, ASK-00820-CL, ASK-01220-UH, ASK-01618-AU, ASK-04018-HF, SAC-00520-1A, SAC-00820-1A, SAC-01220-1A, NA-04020-1A, and others listed under recall number Z-2391-2026. Affected lots include numerous batch codes beginning with 33F and 33S. Distribution was nationwide across all US states and territories including VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, and PR.
What You Should Do
Consumers and healthcare facilities should stop using the affected products and follow instructions from the recalling firm regarding returns or further actions.
Why This Matters
This Class I recall involves nearly half a million medical device kits where potential sterility compromise of included injectable drugs poses a risk of serious or life-threatening injuries.
Source
FDA recall Z-2391-2026, ARROW INTERNATIONAL, LLC, Morrisville, NC. Report date 20260624.
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,722 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.