FDA Recalls high

Arrow International Recalls Arterial Catheter Kits

Source: FDA · United States

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 310,606 units of various arterial catheter kits and sets nationwide due to included drugs subject to a supplier recall with potential sterility issues.

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

This notice was issued by FDA on August 3, 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, medical-devices.

What Happened

ARROW INTERNATIONAL, LLC initiated a voluntary recall of multiple arterial catheter kits and sets after determining that lidocaine, bupivacaine, and 0.9% sodium chloride from a supplier recall were included in the kits. The supplier had quality issues with limited reports of drug ineffectiveness. Compromised sterility of a water-based injectable product could lead to serious or life-threatening injuries.

Which Products Are Affected

The recall covers 310,606 units of the following products distributed nationwide 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:

  • RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A
  • RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A
  • ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA
  • ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM
  • RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC
  • ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC
  • RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC
  • RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV
  • ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1
  • ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS
  • RADIAL ARTERY KIT/ASK-04500-AH
  • RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S
  • ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA
  • ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF
  • ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1
  • ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2
  • ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS
  • ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S
  • ARTERIAL LINE KIT/HF-04510-1
  • RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM
  • RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1
  • RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1
  • RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS
  • RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC
  • RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT
  • RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI
  • RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS
  • RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC
  • RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB
  • RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC
  • RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH
  • RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM
  • RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1
  • RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A
  • RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1
  • CVC KIT: 20 GA X 12CM/ASK-04510-UCLA
  • ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

Affected lots are identified by specific REF numbers and UDI-DI/lot codes listed in FDA recall Z-2397-2026. This is a Class I recall.

What You Should Do

Consumers and healthcare facilities should follow instructions provided in the firm's notification letter and contact ARROW INTERNATIONAL, LLC for return or refund information.

Why This Matters

This Class I recall involves over 310,000 units distributed across the United States, where compromised sterility could result in serious or life-threatening injuries.

Source

FDA Enforcement Report, recall number Z-2397-2026, https://www.fda.gov

Original source: FDA Official Notice ↗

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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 (3,233 characters here).

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Similar severity timing

Same severity (high) notices issued closest in time to August 3, 2026.

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about? ▾
ARROW INTERNATIONAL, LLC is recalling 310,606 units of various arterial catheter kits and sets nationwide due to included drugs subject to a supplier recall with potential sterility issues.
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.

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