FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass I · Medical device · Recalled June 24, 2026

Description/REF recall — ARROW INTERNATIONAL, LLC

Hazard: 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.

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2388-2026
Brand
ARROW INTERNATIONAL
Classification
Class I
Units affected
62,719
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A

Affected products

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): AK-15122-F/10801902197136, 10801902193275, 10801902168525/33F24E0348, 33F24J0280, 33F24K0119, 33F24L0601, 33F25A0477, 33F25C0908, 33F24A0850; ASK-12123-UOC1/10801902193275/33F25B0430, 33F25D0119; ASK-12123-UPM/10801902193275, 10801902222463/33F25E0535, 33F25G0188, 33F25G0189, 33F26C0333, 33F25D0262; ASK-15123-UOC1/10801902193275/33F25C0378, 33F25D0121; ASK-15123-UPM/10801902193275, 10801902159950/33F25E0718, 33F25H0447, 33F26A1389, 33F24E0649; CDC-12123-P1A/40801902111768, 10801902193275/33F24D0632, 33F24F0758, 33F24L0465, 33F25A0281, 33F25E0794; CDC-12123-XP1A/10801902193275, 30801902111785, 10801902213416/33F25J0723, 33F26A1382, 33F26B0433, 36F25A0007, 36F25B0009, 36F25E0018, 33F24D0299; CDC-12123-XPCN1A/10801902213416, 10801902193275/33F24D0950, 33F24K0417, 33F24L0466, 33F25A0216, 33F25B0667, 33F25D0436, 33F25D0666, 33F25E0693, 33F25G0239, 33F25J0247, 33F26A1556, 33F26B0801, 33F26C0767, 33F25B0668; CDC-12123-XPN1A/10801902193275, 10801902213409/33F25D0554, 33F25G0240, 33F25J0312, 33F26B0214,33F26C0199, 33F25A0181; CDC-15123-P1A/10801902193275/33F25D0437, 33F25H0547,33F25B0613; CDC-15123-XPCN1A/10801902213430, 10801902193275/33F24F0107, 33F24F0998, 33F24K0403, 33F24L0834, 33F25A0283, 33F25B0527, 33F25E0650, 33F25E0745, 33F25F0085, 33F25H0596, 33F25J0314, 33F26A1464, 33F26B0883, 33F25B0669; CDC-15123-XPN1A/0801902193275, 10801902213423, 10801902116793/33F25D0439, 33F25G0238, 33F25H0597, 33F25J0315, 33F26A1468, 33F26B0826, 33F24C0461; CDC-16123-XPCN1A/10801902193275/33F25B0671, 33F25D0440, 33F25E0651, 33F25G0236, 33F25H0529, 33F25J0316, 33F25G0237, AK-25122-CDC/10801902193275/33F24G0370, 33F24K0135, 33F25C0120, 33F25C0969, 33F25E0942, 33F24G0371; AK-25142-F/10801902193275, 70801902123205, 10801902167795/33F25C0863, 33F25E0087, 33F25H0038, 33F25J0846, 33F26B0531, 33F24D0089; ASK-22122-MM1/10801902193275/33F25E0546; ASK-22122-MM2/10801902193275, 10801902221923, 10801902144956/33F25G0172, 33F25L0031, 33F25M0310, 33F26A1652, 33F26B0151, 33F26B0450, 33F24F0854; ASK-22142-UOC1/10801902193275/33F25C0545, 33F25D0122; ASK-22142-UPM/10801902193275, 10801902222487, 10801902202281/33F25D0594, 33F25F0116, 33F25G0187, 33F26A1390, 33F26B0205, 33F24D0396; ASK-25142-UNC1/10801902193275/33F25C0655, 33F24K0561; ASK-25142-UOC1/10801902193275/33F25B0362, 33F25D0123; ASK-25142-UPM/10801902193275/33F25E0595, 33F25H0446, 33F25J0381, 33F26A1446, 33F25J0092; ASK-26142-UNC1/10801902193275/33F25B0427, 33F25K0058; AU-22122-F/10801902193275/33F24K0269, 33F25A0584, 33F25C0862, 33F25E0245, 33F25J0567; CDC-22122-1A/20801902123484, 10801902193275/, CDC-22122-XCN1A-U/33F24F0996, 33F24L0374, 33F25C0461; CDC-22122-XN1A/10801902193275/33F25C0239, 33F25E0875, 33F25J0419; CDC-22122-XN1A-U/10801902193275, 10801902213621/33F25A0309, 33F25E0876, 33F26B0217; CDC-22142-1A/50801902123515, 10801902193275/33F24D0928, 33F24F0103, 33F24F0896, 33F24L0111, 33F24L0955, 33F25B0500, 33F25D0447, 33F25E0654, 33F25G0278, 33F25H0577, 33F25J0319; CDC-22142-XC1A/10801902193275/33F25A0284, 33F25J0180; CDC-22142-XCN1A/10801902193275, 10801902213539/33F25A0285, 33F25B0529, 33F25D0449, 33F25E0655, 33F25E0818, 33F25F0214, 33F25G0233, 33F26A1477, 33F26B0898, 33R25J0455; CDC-22142-XCN1A-C/10801902193275/33F24L0473, 33F25B0615, 33F25F0213; CDC-22142-XN1A/10801902193275, 10801902213522/33F25C0240, 33F25E0578, 33F25F0215, 33F25H0528, 33F25J0321, 33F26A1383, 33F26B0215, 33F26C0016; CDC-22142-XN1A-C/10801902193275/33F25B0485, 33F25E0879; CDC-23122-XCN1A-U/10801902193275/33F24L0279, 33F25D0492; CDC-23122-XN1A-U/10801902193275/33F25E0579; CDC-23122-XU1A/10801902193275/33F25D0493, 33F25H0432, 33F25J0248; CDC-25122-1A/10801902193275/33F25B0619, 33F25E0881; CDC-25122-X1A/10801902193275/33F25E0882, 33F25J0422; CDC-25122-XCN1A/10801902213492, 10801902193275/33F24F0929, 33F25C0242, 33F25D0498, 33F25E0883, 33F25G0234, 33F26B0439, 33F26C0214; CDC-25122-XCN1A-U/10801902193275/33F24L1041, 33F25B0620, 33F25F0121, 33F25G0226; CDC-25122-XN1A/10801902193275, 10801902213485/33F25C0243, 33F25E0884, 33F25K0183, 33R25E0884; CDC-25122-XU1A/10801902193275/33F25B0621, 33F25E0886, 33F25H0568; CDC-25142-1A/50801902123584, 10801902193275/33F24F0837, 33F24K0457, 33F24L0113, 33F24L1031, 33F25B0622, 33F25D0503, 33F25E0889, 33F25F0106, 33F25J0127; CDC-25142-XC1A/10801902193275/33F25B0467; CDC-25142-XCN1A/10801902193275, 10801902213553/33F25A0312, 33F25E0657, 33F25E0821, 33F25G0231, 33F25H0527, 33F25J0428, 33F26B0452, 33F26C0133; CDC-25142-XCN1A-C/10801902193275/33F24L0377, 33F25D0238; CDC-25142-XN1A/10801902193275, 10801902213546/33F25B0624, 33F25D0504, 33F25E0823, 33F25G0232, 33F26B0437; CDC-25142-XN1A-C/10801902193275/33F24L0485, 33F25B0676; CDC-26122-1A/60801902123611, 10801902193275/33F24F0084, 33F24K0475, 33F25G0389; CDC-26122-XCN1A/10801902213515, 10801902193275/33F24F1028, 33F24L0117, 33F25D0308, 33F25D0557, 33F25F0219; CDC-26122-XN1A/10801902193275/33F25E0451; CDC-26142-1A/10801902193275/33F24L0488, 33F24L1025, 33F25C0368, 33F25E0891, 33F25H0406, 33F25J0116; CDC-26142-X1A/10801902193275/33F25D0558, 33F25E0892; CDC-26142-XCN1A/10801902193275, 10801902213577/33F24L0941, 33F25B0530, 33F25D0507, 33F25E0699, 33F25H0525, 33F26B0396, 33F26B0895, 33F26C0780; CDC-26142-XN1A/10801902193275, 10801902213560/33F24L0927, 33F25E0580, 33F25H0526, 33F26B0393; AK-25122-F/ CDC-22122-XCN1A/10801902193275/33F24G0371, 33F24L0742, 33F25C0822, 33F25E0084, 33F25J0483, 33F25L0400; CDC-22123-XCN1A/10801902213591, 10801902193275/33F24D0842,33F24F1018, 33F24L0110, 33F25C0205, 33F25D0613, 33F25E0878, 33F26B0455; CDC-25123-XCN1A/10801902213614, 10801902193275/33F24D0818, 33F24L0483, 33F25C0244, 33F25D0502, 33F25E0888, 33F25G0228, 33F25J0425, 33F26B0395, 33F26B0894; CDC-25123-XN1A/10801902193275/33F25C0332, 33F25G0229
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

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

Report a data error on this page