Arrow International Epidural Catheterization Kits Recall
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 1,525,831 units of various epidural catheterization kits distributed nationwide due to inclusion of recalled drugs that may compromise sterility.
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 epidural catheterization kits and spinal anesthesia/epidural cath kits after including lidocaine, bupivacaine, and 0.9% sodium chloride subject to a supplier recall. 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. The recall is classified as Class I and remains ongoing.
Which Products Are Affected
The affected products include numerous models such as EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; and dozens of additional REF numbers including ASK-05500 series, ASK-05501 series, ASK-05502 series, ASK-05503 series, ASK-05560 series, and others listed in the recall. A total of 1,525,831 units were distributed nationwide, including to 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. Specific lot/batch numbers and UDI-DI codes are detailed in FDA recall Z-2371-2026.
What You Should Do
Healthcare providers and facilities should identify and quarantine affected kits. Contact Arrow International, LLC for further instructions regarding the recalled products.
Why This Matters
This Class I recall involves over 1.5 million units of medical devices whose compromised sterility could result in serious or life-threatening injuries.
Source
FDA Enforcement Report, recall number Z-2371-2026, initiated April 21, 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 (1,722 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.