Arrow International Recalls PSI Kits and MAC Kits
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 426,041 PSI and MAC kits distributed nationwide after including lidocaine, bupivacaine, and 0.9% sodium chloride 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 1, 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 PSI KIT and MAC KIT products after determining that lidocaine, bupivacaine, and 0.9% sodium chloride from a supplier with quality issues were included in the kits. The recall is classified as Class I by the FDA.
Which Products Are Affected
The recall covers numerous products including ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; and many additional PSI KIT and MAC KIT models with various REF numbers such as AK-11142-SPCS, CDC-11242-1A, ASK-21142-LMDTG, and others listed in recall Z-2385-2026. A total of 426,041 units were distributed to US Nationwide locations 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. Lot and UDI-DI details are provided in the FDA notice.
What You Should Do
Consumers and healthcare facilities should follow instructions provided in the firm's notification letter regarding the affected kits.
Why This Matters
If sterility of a water-based injectable product is compromised, this could lead to serious or life-threatening injuries.
Source
FDA recall number Z-2385-2026
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 (1,307 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.