FDAClass I · Medical device · Recalled June 24, 2026

Description/REF recall — ARROW INTERNATIONAL, LLC

View the official FDA enforcement record (openFDA) ↗

Official recall ID

Z-2368-2026

Brand

ARROW INTERNATIONAL

Classification

Class I

Units affected

785,999

Recall status

Ongoing

Initiated

Voluntary: Firm initiated

Description

Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

Affected products

• Description/REF

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): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F25C0260, 33F25E0776, 33F25G0332, 33F25J0205, 33F25M0276, 33F26A0305, 33F26B0194, 33F24J0306; ASK-04510-SE/10801902193275, 20801902214038, 10801902217018/33F24K0213, 33F24L0592, 33F25B0251, 33F25C0159, 33F25E0171, 33F25J0527, 33F25L0333, 33F26B0664, 33F24A0873; ASK-04510-TGH2/10801902217018, 10801902193275, 10801902118070/33F24B0292, 33F24C0188, 33F24E0463, 33F24G0289, 33F24K0214, 33F24L0633, 33F25A0542, 33F25C0879, 33F25E0172, 33F25G0120, 33F25J0528, 33F25L0354, 33F25M0862, 33F24C0189; NA-04550-1A/30801902117367, 10801902193275, 33F24A1562, 33F24C0709, 33F24D0331, 33F24E0628, 33F24F0946, 33F24K0382, 33F24L0144, 33F24L1015, 33F25C0223, 33F25D0320, 33F25E0512, 33F25E0663, 33F25E0839, 33F25J0187, 33F25K0199, 33F24K0374; NA-04550-X1A/10801902193275, 30801902117374, 10801902119930/33F24K0704, 33F24L0145, 33F24L1138, 33F25C0465, 33F25C0472, 33F25D0633, 33F25G0387, 33F25J0188, 33F25K0200, 33F26C0354, 33F26C0763, 33F24A1326; AK-04018/10801902190915, 10801902193275, 10801902190939/33F24E0696, 33F24L0051, 33F25A0353, 33F25B0078, 33F25D0714, 33F25G0732, 33F25J0593, 33F26B0039, 33F24A1251; AK-04020/10801902190939, 10801902193275, 60801902121549, 10801902121551/33F24C0727, 33F24C1254, 33F24D0439, 33F24E0697, 33F24F0010, 33F24G0049, 33F24G0116, 33F24G0220, 33F24G0645, 33F24G0646, 33F24G0680, 33F24H0064, 33F24J0013, 33F24J0457, 33F24K0033, 33F24M0004,33F24M0052, 33F24M0070, 33F24M0103,33F24M0146,33F25A0084, 33F25A0335, 33F25A0346, 33F25A0362, 33F25A0397, 33F25B0080, 33F25B0307, 33F25B0414, 33F25C0058, 33F25C0097, 33F25C0494, 33F25C0575, 33F25D0027, 33F25D0083, 33F25D0102, 33F25D0296, 33F25D0703, 33F25F0293, 33F25F0398, 33F25G0493, 33F25H0322, 33F25H0842, 33F25J0037, 33F25J0767, 33F25K0276, 33F25L0154, 33F25L0169, 33F25L0218, 33F26A1264, 33F26A1290, 33F26A1313, 33F26B0291, 33F24C0728, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054, 33F23M0173; AK-04020-C/60801902121549, 10801902193275, 10801902121551/33F24G0050, 33F24G0595, 33F24G0619, 33F24G0681, 33F24H0060, 33F24H0085, 33F24H0244, 33F24J0421, 33F24J0471, 33F24L0074, 33F24L0517, 33F24M0051, 33F24M0102, 33F24M0145,33F25A0354,33F25B0013, 33F25B0079, 33F25B0130, 33F25B0279, 33F25C0096, 33F25C0411, 33F25C0523, 33F25C0595, 33F25D0014, 33F25D0082, 33F25D0169, 33F25E0404, 33F25E1088, 33F25E1164, 33F25F0430, 33F25J1033, 33F25K0343, 33F25L0175, 33F25M0472, 33F26A0212, 33F26A1275, 33F26B0053, 33F26B0290, 33F23M0171; AK-04120/10801902190922, 10801902193275, 20801902121572/33F24A1254, 33F24B0432, 33F24C0731, 33F24D0440, 33F24E0701, 33F24H0444, 33F24J0006, 33F24K0623, 33F24L0035, 33F24M0127, 33F25A0129, 33F25B0057, 33F25B0328, 33F25E1096, 33F25F0405, 33F25F0522, 33F25G0511, 33F25J1067, 33F26C0419, 33F24C0789; AK-04122/20801902121572, 10801902193275, 10801902121582/33F24G0051, 33F24G0148, 33F24G0682, 33F24K0535, 33F24M0071, 33F25A0092, 33F25A0380, 33F25B0005, 33F25D0108, 33F25J0762, 33F25K0003, 33F24A1009; AK-04220/10801902190946, 10801902193275, 10801902121636/33F24C0733, 33F24E0703, 33F24G0117, 33F24G0223, 33F24G0683, 33F24H0246, 33F24H0414, 33F24J0009, 33F24J0447, 33F24M0003, 33F24M0086, 33F25C0085, 33F25D0171, 33F25G0065, 33F25J0059, 33F26C0392, 33F24A1257; ASK-04020-AH/10801902193275, 10801902114898/33F24L0219, 33F24L0398, 33F24L0950, 33F25B0174, 33F25C0436, 33F25D0332, 33F25D0648, 33F25E0848, 33F25H0647, 33F25J0350, 33F26C0572, 33F24G0403; ASK-04020-ATH/10801902193275, 10801902193237, 10801902205916/33F24J0553, 33F24K0167, 33F24L0777, 33F25C0133, 33F25C0982, 33F25E0964, 33F25G0106, 33F25G0670, 33F25H0063, 33F25H0727, 33F25L0242, 33F25L0452, 33F25M0947, 33F26B0583, 33F24D0856; ASK-04020-AU2/10801902205916, 10801902193275, 10801902117660/33F24E0645, 33F24F1044, 33F24K0365, 33F24L1020, 33F25A0230, 33F25C0225, 33F25D0333, 33F25E0523, 33F25E0849, 33F25H0474, 33F25J0199, 33F25L0120, 33F25M0208, 33F26A1419, 33F26B0449, 33F26C0030, 33F24A0814; ASK-04020-BHS/10801902193275, 30801902144578, 10801902211429/33F25A0231, 33F25D0589, 33F25E0850, 33F25F0095, 33F25G0320, 33F25J0200, 33F26A1514, 33R24D0228, 33S24C0678, 33S24C1077, 33F24D0277; ASK-04020-BIDB2/10801902193275/33F24K0168, 33F25A0508, 33F25C0134, 33F25C0835, 33F25E0121, 33F25G0107, 33F25H0065, 33F25H0728, 33F25J0669, 33F25K0399, 33F25L0429, 33F25M0929, 33F24J0365; ASK-04020-CCD1/10801902193275/33F24J0289, 33F24J0556, 33F24L0641, 33F25A0510, 33F25C0772, 33F25E0123, 33F25G0108, 33F25H0730, 33F25M0874, 33F24G0282; ASK-04020-CR/10801902193275, 10801902206814/33F24K0169, 33F24L0679, 33F25A0511, 33F25C0785, 33F25E0124, 33F25E0969, 33F25G0109, 33F25G0669, 33F25H0067, 33F25H0731, 33F25J0868, 33F25L0241, 33F25M0881, 33F26B0523, 33F24G0407; ASK-04020-EUH2/10801902193275, 10801902213379, 10801902193244/33F24J0290, 33F24J0557, 33F24L0753, 33F25A0512, 33F25C0930, 33F25E0125, 33F25H0068, 33F25J0869, 33F25M0894, 33F26B0236, 33F23H0888; ASK-04020-FAM1/10801902193275/ 33F24H0374, 33F24J0181, 33F24L0734, 33F25C0135, 33F25C0781, 33F25E0126, 33F25E0970, 33F25J0502, 33F24G0408; ASK-04020-FMC/10801902193275, 10801902121384/33F24J0558, 33F24K0171, 33F25A0513, 33F25C0773, 33F25E0127, 33F25E0971, 33F25H0069, 33F25J0870, 33F25L0388, 33F25M0892, 33F24A0828; ASK-04020-KSF2/10801902193275/33F25A0516, 33F25C0851, 33F25E0132, 33F25H0075, 33F25J0876, 33F25M0906, 33F24K0178; ASK-04020-LHC2/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672; ASK-04020-LHC3/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672, 33F24L0653; ASK-04020-LM/10801902193275/33F25B0690, 33F25E0977, 33F25H0076, 33F25J0877, 33F25L0422, 33F25M0925, 33F24G0417; ASK-04020-MCH1/10801902193275, 20801902117711/33F24L0920, 33F24A0380; ASK-04020-MIH1/10801902193275/33F24L0744, 33F25A0522, 33F25C0978, 33F25E0138, 33F25H0080, 33F25J0879, 33F26A0996, 33F25A0442; ASK-04020-NWMX/10801902193275/33F24K0186, 33F25J0882, 33F25L0363, 33F25M0872, 33F24G0423; ASK-04020-PHP/10801902193275, 10801902138498/33F24K0187, 33F25A0148, 33F25C0401, 33F25D0283, 33F25E1145, 33F25J1027, 33F24C0164; ASK-04020-RIHM/10801902193275/33F24L0243, 33F24L1034, 33F25B0177, 33F25C0256, 33F25D0462, 33F25E0525, 33F25E0773, 33F25G0317, 33F25H0645, 33F25J0351, 33F26A1408, 33F24M0095; ASK-04020-RMC1/10801902193275/33F25J0509, 33F25L0464, 33F24L0747; ASK-04020-RU/10801902193275/33F25A0524, 33F25C0807, 33F25E0143, 33F25G0112, 33F25J0510, 33F25M0863, 33F24G0427; ASK-04020-SE/10801902193275, 10801902213263, 10801902138757/33F24L0611, 33F25A0525, 33F25C0849, 33F25E0144, 33F25E0984, 33F25J0511, 33F26B0999, 33F24E0433; ASK-04020-SHM/10801902193275/33F24G0428, 33F24J0576, 33F24K0190, 33F24L0684, 33F25A0526, 33F25C0971, 33F25E0145, 33F25G0113, 33F25J0512, 33F25L0378, 33F25M0883, 33F25C0143; ASK-04020-SRMC1/10801902193275, 10801902117837/33F24J0296, 33F24K0192, 33F24L0710, 33F25C0144, 33F25C0820, 33F25E0146, 33F25H0086, 33F25J0884, 33F25M0842, 33F24A0868; ASK-04020-UCL1/10801902193275, 10801902144550/33F24K0412, 33F24L1081, 33F25A0233, 33F25C0257, 33F25D0393, 33F25E0774, 33F25G0360, 33F25J0201, 33F26B0160, 33F24G0178; ASK-04020-UMI/10801902193275, 10801902145571/33F24L1123, 33F24E0726; ASK-04020-UN/10801902145571, 10801902193275, 60801902117849/33F24K0021, 33F24L0533, 33F24M0053, 33F24M0107, 33F25A0089, 33F25B0016, 33F25B0092, 33F25B0314, 33F25D0015, 33F25D0113, 33F25D0172, 33F25E1146, 33F25H0797, 33F25K0230, 33F26B0090, 33F26B0262, 33F24A0373; ASK-04020-UNC/60801902117849, 10801902193275, 10801902143782/33F24A1035, 33F24B0270, 33F24C0170, 33F24G0432, 33F24J0297, 33F24J0577, 33F24L0799, 33F25A0527, 33F25C0145, 33F25C0994, 33F25E0147, 33F25H0088, 33F25J0513, 33F25L0359, 33F25M0868, 33F26A0993, 33F26B0975, 33F24F0461; ASK-04020-UNC1/10801902193275, 10801902143782, 10801902117851/33F24G0286, 33F24J0298, 33F24K0194, 33F24L0806, 33F25C0146, 33F25E0148, 33F25H0089, 33F25J0514, 33F25L0469, 33F25M0959, 33F26C0599, 33F24A0255; ASK-04220-PSU/10801902193275/33F25A0152, 33F25H0737, 33F24K0495; ASK-04220-UCL1/10801902193275, 10801902159127, 10801902143805/33F24L0290, 33F25A0206, 33F25C0226, 33F25D0463, 33F25E0669, 33F25G0351, 33F25H0428, 33F25J0352, 33F26B0153, 33F24F0619; NA-04020-S1A/10801902193275, 10801902139396/33F25A0600, 33F25C0195, 33F25C0786, 33F25E0270, 33F25E1050, 33F25G0152, 33F25H0177, 33F25H0759, 33F25J0633, 33F25K0404, 33F25L0472, 33F25M0962, 33F26B0595, 33F24J0683; ASK-04550-JMC1/10801902193275, 10801902130836/33F25C0837, 33F25E0175, 33F25E0997, 33F25L0146, 33F24F0685; ASK-04001-BW2/10801902193275, 10801902221602/33F25A0500, 33F25E0110, 33F25H0057, 33F25J0496, 33F25L0360, 33F26A0994, 33S23M0157, 33F25A0226; ASK-04001-WUH1/10801902193275, 10801902220834, 10801902119268/33F24J0549, 33F24K0162, 33F24L0685, 33F25H0061, 33F25J0864, 33F26B0683, 33F26B1021, 33F24A0078; ASK-04510-HUM/10801902115048/33F24C0956, 33F24D0699, 33F24E0647, 33F24F0911, 33F24L0885

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 24, 2026 at 3:00 AM UTC.

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