Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A — Class I medical device recall Z-2397-2026

Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-06-24, distributed nationwide. Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits an

Recall number	`Z-2397-2026`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	ARROW INTERNATIONAL, LLC, Morrisville, NC, United States
Recall initiated	2026-04-21
Classified	2026-06-12
Reported by FDA	2026-06-24
Distributed	Nationwide (US)
Quantity	310,606
Reason classes	sterility
UPC / GTIN / UDI-DI	`10801902114041`, `10801902114089`, `10801902117585`, `10801902117691`, `10801902117721`, `10801902117769`, `10801902117776`, `10801902117783`, `10801902117837`, `10801902117851`, `10801902117929`, `10801902118001`, `10801902118025`, `10801902118049`, `10801902118070`, `10801902119268`, `10801902119824`, `10801902119855`, `10801902121384`, `10801902124927`, `10801902128536`, `10801902162943`, `10801902193275`, `10801902224177`, `30801902119927` and 2 more
Lot numbers	`10801902117837/33F24A0868`, `10801902117929/33F24G0440`, `10801902118025/33F24G0450`, `10801902119824/33F24L0738`, `10801902128536/33F24K0173`, `10801902193275/33F23B0953`, `10801902193275/33F24A0094`, `10801902193275/33F24A0141`, `10801902193275/33F24A0153`, `10801902193275/33F24A0255`, `10801902193275/33F24A0324`, `10801902193275/33F24A0751`, `10801902193275/33F24A0792`, `10801902193275/33F24A0828`, `10801902193275/33F24A0864`, `10801902193275/33F24A0872`, `10801902193275/33F24B0465`, `10801902193275/33F24C0160`, `10801902193275/33F24C0189`, `10801902193275/33F24D0036`, `10801902193275/33F24D0139`, `10801902193275/33F24F0095`, `10801902224177/33F25K0324`, `30801902119927/33F24J0683`, `33F24A0385`, `33F24A0389`, `33F24A0743`, `33F24A0753`, `33F24A0803`, `33F24A1037`, `33F24A1138`, `33F24A1157`, `33F24B0019`, `33F24B0140`, `33F24B0141`, `33F24B0246`, `33F24B0248`, `33F24B0259`, `33F24B0260`, `33F24B0269` and 341 more
Model numbers	`1-1/2IN`, `1-1/2IN/NA-04220-1A`, `1-1/2IN/NA-04220-X1A`, `1-3/4`, `1-3/4IN`, `1-3/4IN/ASK-04020-BSM`, `1-3/4IN/ASK-04020-HC`, `1-3/4IN/WBH-04020-1`, `10801902117837/33F24A0868`, `10801902117929/33F24G0440`, `10801902118025/33F24G0450`, `10801902119824/33F24L0738`, `10801902128536/33F24K0173`, `10801902193275/33F23B0953`, `10801902193275/33F24A0094`, `10801902193275/33F24A0141`, `10801902193275/33F24A0153`, `10801902193275/33F24A0255`, `10801902193275/33F24A0324`, `10801902193275/33F24A0751`, `10801902193275/33F24A0792`, `10801902193275/33F24A0828`, `10801902193275/33F24A0864`, `10801902193275/33F24A0872`, `10801902193275/33F24B0465` and 372 more

Product

Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2397-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.