Arrow International Recalls Biopsy System Comprehensive Kits
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ARROW INTERNATIONAL, LLC is recalling 14,840 Biopsy System Comprehensive Kits (various ASK-09458 models) distributed nationwide due to included drugs from 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, Devices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of Biopsy System Comprehensive 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.
Which Products Are Affected
Affected products are BIOPSY SYSTEM COMPREHENSIVE KIT with REF numbers ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, and ASK-09458-VU. Total quantity recalled: 14,840 units. Specific lot/batch and UDI-DI details are listed under recall number Z-2365-2026. Distributed to US 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.
What You Should Do
Consumers should refer to the recall notice from ARROW INTERNATIONAL, LLC at 3015 Carrington Mill Blvd, Morrisville, NC 27560-5437 for further guidance on affected units.
Why This Matters
This Class I recall involves potential sterility compromise that could result in serious or life-threatening injuries.
Source
FDA recall Z-2365-2026 (event ID 98793), 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 (1,347 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.