FDAClass I · Medical device · Recall Z-2379-2026 · Recalled June 24, 2026

Description/REF recall — ARROW INTERNATIONAL, LLC

Agency report date: June 24, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Description/REF
Company / brand: ARROW INTERNATIONAL
Lot / serial / date codes: REF(Material)/UDI-DI/Lot(Batch): ASK-41552-LTAC/10801902193275/33F24J0142, 33F24H0002; ASK-42063-LTAC/10801902214925/33F24F1005; CDC-41541-JX1A/10801902193275/33F25H0768; CDC-41552-JX1A/10801902193275, 10801902201505/33F25A0185, 33F25E0826, 33F24D0561; CDC-41563-JX1A/10801902193275/33F25B0150; CDC-42041-JX1A/10801902193275, 10801902188288/33F25E0751, 33F26C0353, 33F25A0186; CDC-42052-JX1A/10801902193275/33F25G0312, 33F24J0131; CDC-42063-JX1A/10801902193275/33F25C0447, 33F25D0516, 33F25E0752, 33F25J0436, 33F25C0370
Distribution: US Nationwide distribution including in 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, PR.

Agency product description and boundaries

Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class I: most serious — reasonable probability of serious health consequences or death.

Affected product: Description/REF recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2379-2026
Brand: All ARROW INTERNATIONAL recalls
Classification: Class I
Units affected: 1,516
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Description/REF recall status

Companies & origin

Recalling firm location: Morrisville, NC, United States
Firm address: 3015 Carrington Mill Blvd, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots: REF(Material)/UDI-DI/Lot(Batch): ASK-41552-LTAC/10801902193275/33F24J0142, 33F24H0002; ASK-42063-LTAC/10801902214925/33F24F1005; CDC-41541-JX1A/10801902193275/33F25H0768; CDC-41552-JX1A/10801902193275, 10801902201505/33F25A0185, 33F25E0826, 33F24D0561; CDC-41563-JX1A/10801902193275/33F25B0150; CDC-42041-JX1A/10801902193275, 10801902188288/33F25E0751, 33F26C0353, 33F25A0186; CDC-42052-JX1A/10801902193275/33F25G0312, 33F24J0131; CDC-42063-JX1A/10801902193275/33F25C0447, 33F25D0516, 33F25E0752, 33F25J0436, 33F25C0370
Distribution: US Nationwide distribution including in 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, PR.
Firm notified the public via: Letter
FDA event ID: 98793
Recall initiated: April 21, 2026
FDA classified: June 12, 2026
FDA report date: June 24, 2026

More ARROW INTERNATIONAL recalls

Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026

Other medical device recalls from around the same time

Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Impella CP Set with SmartAssist recall — Abiomed, Inc.FDA · June 24, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 22, 2026 at 6:00 PM UTC.

Report a data error on this page