Arrow International Recalls Drainage and Thoracentesis Kits
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Arrow International, LLC is recalling 444,943 units of various drainage, thoracentesis, and pneumothorax 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 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, Devices.
What Happened
Arrow International, LLC initiated a voluntary recall of multiple procedure kits after determining that lidocaine, bupivacaine, and 0.9% sodium chloride from a supplier with quality issues were included in the kits. The supplier recall involved limited reports of drug ineffectiveness, and compromised sterility of water-based injectable products could lead to serious or life-threatening injuries.
Which Products Are Affected
The recall covers 444,943 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:
- DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM
- THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS
- PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM Multiple lots with specific REF and UDI-DI codes are affected. The FDA recall number is Z-2382-2026. Classification: Class I.
What You Should Do
Consumers should contact Arrow International, LLC for further instructions regarding the recalled kits.
Why This Matters
This Class I recall involves a large quantity of medical procedure kits where compromised sterility could result in serious or life-threatening injuries.
Source
FDA recall number Z-2382-2026, report date 20260624.
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 (1,577 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.