Arrow International Paracentesis Kit Recall
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ARROW INTERNATIONAL, LLC is recalling 180 Paracentesis Kits due to inclusion of drugs subject to a supplier recall with potential quality and sterility issues that could cause serious injury.
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 Paracentesis Kits after determining that Lidocaine, Bupivacaine, and 0.9% sodium chloride included in the kits were subject to a supplier recall. The supplier had quality issues and limited reports of drug ineffectiveness. If sterility of a water-based injectable product is compromised, this could lead to serious or life-threatening injuries.
Which Products Are Affected
The recall affects the PARACENTESIS KIT with REF/Description ASK-00376-JHH. Affected lots include 33F25G0629 and 33F24K0592 (UDI-DI: 10801902193275). A total of 180 units were distributed nationwide in the United States, including the states of 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. The FDA recall number is Z-2386-2026 and the event ID is 98793. This is a Class I recall.
What You Should Do
Consumers and healthcare facilities should contact ARROW INTERNATIONAL, LLC for information regarding the recall.
Why This Matters
The potential compromise in sterility or drug effectiveness in these kits poses a risk of serious or life-threatening injuries.
Source
FDA Recall Z-2386-2026 - 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 (1,384 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.