Recall archive / FDA device enforcement

Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-... — FDA record Z-2384-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 21, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH; MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1; CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH; CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM; CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1; PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1; PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2; MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2; PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1; PI CVC KIT: 2L 8 FR/ASK-42802-TGH1; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1; CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH; 3L CVC ...
Reason: 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.
Classification: Class I
Recalling firm: ARROW INTERNATIONAL, LLC
Quantity: 1,061,069
Agency-reported status: Ongoing
Source record identifier: Z-2384-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	REF(Material)/UDI-DI/Lot(Batch): ASK-04001-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275, 10801902214338/33F24F0787, 33F24L0304, 33F25A0242, 33F25C0268, 33F25D0470, 33F25E0537, 33F25E0854, 33F25J0365, 33F25M0247, 33F26A1555, 33F26B0855, 33F26C0742, 33F24K0672; ASK-12703-WMC2/10801902193275/33F24K0493, 33F24L0305, 33F25B0156, 33F25E0593, 33F25H0483, 33F25J0367, 33F25M0218, 33F24K0545; ASK-15703-LMDT1/10801902193275/33F24J0164, 33F24L0307, 33F25B0192, 33F25C0230; ASK-15703-LMDTG1/10801902193275/33F25D0537, 33F25E0670, 33F25G0295, 33F25J0146, 33F25K0093, 33F25M0138, 33F26B0131, 33F25E0312; ASK-15703-PVH/10801902133226, 10801902193275, 10801902210217/33F24D0809, 33F24F0669, 33F24K0462, 33F24L0226, 33F25A0167, 33F25B0193, 33F25B0547, 33F25D0265, 33F25D0653, 33F25G0169, 33F25G0404, 33F25J0369, 33F26A1459, 33F24M0270; ASK-24301-JHH1/10801902193275, 10801902214819, 10801902210217/33F25A0170, 33F25B0552, 33F25E0547, 33F25G0222, 33F25L0056, 33F26B0421, 33F24E0546; CDC-24306-1A/30801902116919, 10801902193275, 30801902116919/33F24D0786, 33F24E0620, 33F24F0926, 33F24K0446, 33F24L0990, 33F25A0310, 33F25D0495, 33F25E0880, 33F25J0323, 33F26B0377, 33F26C0693, 33F24L1111; CDC-24703-X1A/10801902193275/33F25D0497, 33F25E0748, 33F25G0318, 33F25H0570, 33F25J0325, 33F26A1563, 33F25B0619; CDC-25123-1A/10801902193275, 10801902191622/33F24H0012, 33F24L0481, 33F25C0445, 33F25D0500, 33F25F0382, 33F25G0258, 33F26A1560, 33F26B0394, 33F25B0675; ASK-42802-ECL3/10801902193275/33F25E0567, 33F25F0128, 33F25H0464, 33F25J0286, 33F26A1399; ASK-42703-ACH/10801902193275, 30801902119514/33F24L0327, 33F24L1064, 33F25C0292, 33F25E0675, 33F25H0420, 33F25J0267, 33F25L0122, 33F25M0091, 33F26A1505, 33F24D0032; ASK-42703-BJC1/10801902193275, 10801902202519/33F24K0500, 33F24L0328, 33F25B0556, 33F25G0173, 33F25J0268, 33F26A1513, 33F26B0767, 33F25C0744; ASK-42703-DU1/10801902193275, 1080190216099/33F25B0141, 33F25C0232, 33F25E0786, 33F25J0105, 33F25M0014, 33F26C0342, 33F24F0060; ASK-42703-EMC/10801902160475, 10801902118421/33F24F0881, 33F25A0214, 33F25C0293, 33F25D0596, 33F25H0632, 33F25M0115, 33F26C0343, 33F24F0132; ASK-42703-LMDT1/10801902205657, 10801902193275/33F24F0688, 33F24J0157, 33F24L0228, 33F24L0329, 33F24L1096, 33F25A0252, 33F25B0557, 33F25C0352, 33F25E0557, 33F25E0722, 33F25G0400, 33F25K0139, 33F26A1370, 33F26B0210, 33F25C0294; ASK-42703-LMDTG1/10801902193275, 10801902205695, 10801902220896/33F25E0558, 33F25E0860, 33F25G0271, 33F25G0399, 33F25H0419, 33F26B0387, 33F24G0070; ASK-42703-MCY1/10801902193275, 0801902220896/33F24H0198, 33F24K0425, 33F25A0198, 33F25B0651, 33F25C0353, 33F25D0405, 33F25E0676, 33F25H0452, 33F25J0220, 33F25M0183, 33F26A1479, 33F26B0863, 33F25H0409; ASK-42703-NS1/10801902193275, 10801902216479/33F25A0300, 33F25B0652, 33F25C0375, 33F25E0723, 33F25H0459, 33F25J0221, 33F26A1579, 33F26B0825, 33F25C0354; ASK-42703-PAGP1/10801902193275, 10801902158717, 10801902136685/33F25D0406, 33F25E0560, 33F25E0790, 33F25H0560, 33F25L0114, 33F26A1353, 33F26A1506, 33F26B0751, 33F24D0181; ASK-42703-PAM1/10801902136685, 10801902193275/33F24E0310, 33F24L0895, 33F25A0256, 33F25B0496, 33F25C0477; ASK-42703-PAMC2/10801902193275, 10801902217131/33F25F0188, 33F25J0270, 33F26C0161, 33F24K0400; ASK-42703-PAU1/10801902193275/33F24L0414, 33F25B0143, 33F25C0474, 33F25G0397, 33F25M0313, 33F26A1349, 33F25B0232; ASK-42703-PB1/10801902193275, 10801902220377/33F25E0458, 33F25K0427, 33F24F0065; ASK-42703-PBSWH2/10801902220377, 10801902193275, 10801902220377, 10801902203189/33F24F0651, 33F24K0368, 33F24L0230, 33F24L0415, 33F24L1079, 33F25B0167, 33F25C0440, 33F25D0539, 33F25E0014, 33F25E0596, 33F25G0205, 33F25H0511, 33F25J0222, 33F25K0112, 33F25M0394, 33F26B0412, 33F24D0720; ASK-42703-PCAM1/10801902203189, 10801902193275, 10801902141030/33F24F0675, 33F24L1058, 33F25B0560, 33F25C0355, 33F25D0351, 33F25E0725, 33F25G0366, 33F25J0386, 33F25M0388, 33F26B0791, 33F24F0874; ASK-42703-PCSJ2/10801902193275, 10801902211672/33F25H0468, 33F25J0271, 33F26B0389, 33F26C0179, 33S24L0906, 33F25B0445; ASK-42703-PECL2/10801902193275/33F25H0466, 33F25J0272, 33F26A0011; ASK-42703-PGM4/10801902193275, 10801902221824/33F25B0653, 33F25D0541, 33F25J0106, 33F25J0387, 33F25K0140, 33F26B0749, 33F26C0027, 33F25E1195; ASK-42703-PHHN1/10801902193275, 10801902144734/33F25H0486, 33F25K0064, 33F25M0673, 33F26A0249, 33F26B0906, 33F25E0009; ASK-42703-PLC/10801902193275/33F25D0407, 33F25E0791, 33F25F0099, 33F25H0606, 33F26A1393, 33F25E1196; ASK-42703-PMEM/10801902193275, 10801902142167/33F25G0554, 33F25K0054, 33F25L0256, 33F26C0050, 33F24L0418; ASK-42703-PMHC1/10801902193275/10801902135244/33F25E0561, 33F25H0430, 33F25H0638, 33F25J0388, 33F25M0232, 33F26B0135, 33F26B0796, 33F25F0363; ASK-42703-PNHS1/10801902193275, 10801902225495/33F25D0542, 33F25E0599, 33F25H0498, 33F25H0650, 33F26D0066; ASK-42703-POHU2/10801902193275, 10801902212020/33F25E0562, 33F25G0284, 33F25J0389, 33F26A1421, 33F24F0662; ASK-42703-POSU2/10801902193275/33F24K0401, 33F24L0419, 33F24L0949, 33F25B0446, 33F25D0758; ASK-42703-PTJH/10801902193275, 10801902219012/33F24L0190, 33F25A0015, 33F25B0366, 33F25C0658, 33F25E0316, 33F24E0660; ASK-42703-PUCH2/10801902219012, 10801902193275, 10801902219012, 10801902135022/ ASK-42703-PUCI1/33F24F1025, 33F24L0336, 33F24L1009, 33F25B0476, 33F25C0356, 33F25E0021, 33F25F0189, 33F25H0455, 33F25J0275, 33F25K0142, 33F25M0120, 33F26A1518, 33F26B0182, 33F26B0781, 33F24F0850; ASK-42703-PUHC2/10801902193275, 10801902159608/33F25D0353, 33F25E0602, 33F25G0288, 33F25H0635, 33F25J0277, 33F25K0143, 33F26B0386, 33F26C0149, 33F24D0765; ASK-42703-PUMH/10801902129465, 10801902193275, 10801902159592/33F24F0697, 33F24K0709, 33F24L0997, 33F25C0301, 33F25E0677, 33F25J0278, 33F26A0256, 33F26B0789, 33F26C0227, 33F24D0698; ASK-42703-PUPM1/10801902159592, 10801902193275, 10801902225150/33F24F0761, 33F24K0499, 33F24L1074, 33F25B0519, 33F25C0357, 33F25D0354, 33F25D0598, 33F25E0678, 33F25G0346, 33F25J0279, 33F25M0126, 33F26B0363; ASK-42703-SHUF2/10801902193275, 10801902208368/33F25D0355, 33F25E0792, 33F25H0473, 33F25J0280, 33F25M0204, 33F26A1501, 33F26B0832, 33F24L0339; ASK-42703-SL1/10801902193275, 10801902205206/33F25B0483, 33F25C0443, 33F25D0482, 33F25E0793, 33F25G0306, 33F25J0281, 33F26A1437, 33F24D0631; ASK-42703-UMC/10801902193275, 10801902205206/33F24K0363, 33F24L0340, 33F25B0568,33F25E0801, 33F25G0328, 33F25J0282, 33F25M0194, 33F26A1444, 33F26B0769, 33F26C0221, 33F25B0158; ASK-42703-WHH/10801902193275, 10801902159189, 30801902119576/33F25E0565, 33F25G0350, 33F25J0283, 33F26B0777, 33F24E0552; ASK-42802-CHM/10801902193275/33F24H0178, 33F24K0480, 33F24L0859, 33F25D0236, 33F25F0190, 33F25H0518, 33F25J0284, 33F25M0139, 33F26B0175, 33F25E0005; ASK-42802-LMDT1/10801902205664, 10801902193275/33F24F0737, 33F24K0381, 33F24L0250, 33F24L0423, 33F25B0570, 33F25C0377, 33F25F0129, 33F25G0281, 33F25J0158, 33F25K0146, 33F26C0156, 33F25F0533; ASK-42802-MCY1/10801902193275, 10801902220384/33F24K0328, 33F24K0754, 33F24F0964; ASK-42802-PBSWH2/10801902193275, 10801902220384/33F24H0200, 33F24K0408, 33F24L0424, 33F24L1006, 33F25B0477, 33F25D0357, 33F25G0203, 33F25G0204, 33F25H0659, 33F25J0390, 33F25M0195, 33F25M0335, 33F26B0424, 33F24F0759; ASK-42802-POSU2/10801902193275/33F24K0473, 33F25D0759; ASK-42802-PUNCC2/10801902164251, 10801902193275, 10801902159585/33F24F0948, 33F24L0425, 33F25H0443, 33F25J0394, 33F24D0660; ASK-42802-PUPM1/10801902159585, 10801902193275, 10801902225143/33F24F0668, 33F24K0422, 33F24L0341, 33F24L1042, 33F25C0305, 33F25E0679, 33F25F0194, 33F25J0159, 33F25M0123, 33F26B0364; ASK-42802-TGH1/10801902213829, 10801902193275, 10801902213829/33F24L1054, 33F25B0521, 33F25D0311, 33F25E0604, 33F25G0225, 33F25J0288, 33F25L0204, 33F26A1543, 33F26B0844, 33F26C0224, 33F25C0306; ASK-42854-BJC1/10801902202540, 10801902193275, 10801902202540/33F24F0644, 33F24K0348, 33F24L0232, 33F25A0260, 33F25B0571, 33F25D0358, 33F25D0601, 33F25E0863, 33F25G0367, 33F26A1524, 33F26B0764, 33F26C0140, 33F24H0126; ASK-42854-PBMH/10801902193275, 40801902131469/33F26A0241, 33F24E0639; ASK-42854-PMM/40801902131469, 10801902193275/33F24F1014, 33F24L1013, 33F25C0307, 33F25D0546, 33F25E0802, 33F25H0480, 33F25J0398, 33F25A0019; ASK-42854-PUCH2/10801902193275, 10801902219050/33F25K0065, 33F26B0902, 33F24L0347; ASK-45703-ACH/10801902193275, 10801902203257, 30801902119644/33F25B0235, 33F25E0007, 33F25F0237, 33F25K0046, 33F25M0675, 33F26B0221, 33F24D0033; ASK-45703-ARM/10801902193275, 1080190215812/33F24L0903, 33F25B0449, 33F25D0363, 33F25E0682, 33F25H0479, 33F25J0228, 33F25K0150, 33F26A1423, 33F26B0849, 33F25F0004; ASK-45703-BJC1/10801902193275, 10801902202533, 10801902213782/33F24K0426, 33F24L0826, 33F25B0450, 33F25B0577, 33F25D0547, 33F25F0104, 33F25F0199, 33F25M0096, 33F26A1348, 33F26B0378, 33F26B0750, 33F24F0776; ASK-45703-BLH/10801902193275, 10801902213782, 10801902135381/33F24L1067, 33F25J0110, 33F25K0071, 33F25K0151, 33F25M0331, 33F26A1457, 33F26B0776, 33F24F0165; ASK-45703-DU1/10801902193275, 10801902160970, 10801902160468/33F25B0451, 33F25D0548, 33F25E0683, 33F25H0558, 33F26A1451, 33F26B0208, 33F26B0707, 33F26B0845, 33F24D0579; ASK-45703-HHC4/10801902193275, 10801902211467, 10801902205671/33F25D0364 ,33F25D0661, 33F25E0867, 33F25G0246, 33F25H0598, 33F25J0229, 33F25M0152, 33F26A1537, 33F26B0818, 33S25E0867, 33F24F0873; ASK-45703-LMDT1/10801902193275, 10801902205671/33F24K0440, 33F24L0432, 33F24L0919, 33F25B0160, 33F25D0365, 33F25D0603, 33F25E0608, 33F25G0326, 33F25H0475, 33F25J0230, 33F25M0153, 33F26A1552, 33F26B0880, 33F25B0453; ASK-45703-LMDTG1/10801902193275, 10801902205749, 10801902220902/33F25B0579, 33F25E0018, 33F25E0609, 33F25F0200, 33F25G0398, 33F25J0401, 33F25M0190, 33F25M0332, 33F26B0482, 33F26C0226, 33F24G0072; ASK-45703-MCY1/10801902193275/33F24J0132, 33F24K0445, 33F24L0433, 33F24L1028, 33F25B0657, 33F25E0022, 33F25E0610, 33F25F0201, 33F25H0657, 33F25M0144, 33F26A1573, 33F25L0143; ASK-45703-NO/10801902205213, 10801902193275, 10801902216417/33F24F0844, 33F24L0352, 33F25B0581, 33F25E0611, 33F24D0769; ASK-45703-NS1/10801902216417, 10801902193275, 10801902216417/33F24F0835, 33F24L0434, 33F24L1047, 33F25E0612, 33F25F0130, 33F25G0214, 33F25M0176, 33F26A1544, 33F26B0864, 33F25F0006; ASK-45703-PADV1/10801902193275/33F24J0146, 33F24K0458, 33F24L0353, 33F25C0311, 33F25E0423, 33F25E0684, 33F25H0561, 33F25M0127, 33F26A0775, 33F25A0265; ASK-45703-PAGP1/10801902193275, 10801902158724/33F25E0613, 33F25F0202, 33F25G0409, 33F25J0297, 33F26A1339, 33F26C0125, 33F25B0658; ASK-45703-PAMC1/10801902193275, 10801902217148, 10801902208344/33F25D0549, 33F25E0728, 33F25J0298, 33F25K0152, 33F26B0199, 33F24D0738; ASK-45703-PAU1/10801902208344, 10801902193275, 10801902220353/33F24F0783, 33F24L0354, 33F25D0483, 33F25E0729, 33F25H0534, 33F25J0404, 33F24F0070; ASK-45703-PBSWH2/10801902220353, 10801902193275, 10801902220353, 10801902203158/33F24F0937, 33F24L0437, 33F24L1112, 33F25A0306, 33F25B0659, 33F25E0614, 33F25E0803, 33F25F0080, 33F25H0368, 33F25H0513, 33F25K0153, 33F25M0191, 33F26C0157, 33F24F0660; ASK-45703-PCAM1/10801902193275/33F24L0355, 33F25C0312, 33F25E0016, 33F25E0804, 33F25J0162, 33F26A1447, 33F24K0479; ASK-45703-PCSJ2/10801902193275, 10801902211689, 10801902202861/33F25G0245, 33F25J0165, 33F25K0155, 33F26A1546, 33F26B0853, 33F24D0896; ASK-45703-PDM1/10801902202861, 10801902193275/33F24F0747, 33F25A0268, 33F25B0584, 33F25D0368, 33F25D0604, 33F25E0617, 33F25G0330, 33F25H0612, 33F25J0166, 33F25M0196, 33F26A1460, 33F25B0585; ASK-45703-PECL2/10801902193275/33F25D0369, 33F25D0605, 33F25E0619, 33F25G0242, 33F25J0168, 33F26A0013; ASK-45703-PGM4/10801902193275, 10801902221817/33F25B0660, 33F25D0412, 33F25J0169, 33F25K0078, 33F26C0176, 33F24M0174; ASK-45703-PGVH/10801902193275, 10801902200508/33F25E0310, 33F25H0781, 33F24F0101; ASK-45703-PHF4/)10801902200508, 10801902193275/33F24F0887, 33F24L0253, 33F24L0439, 33F25A0269, 33F25B0586, 33F25C0314, 33F25D0606, 33F25E0575, 33F25F0118, 33F25M0060, 33F25M0170, 33F26A1480,...

Label field

Details supplied by the agency

Lot, code or applicability

REF(Material)/UDI-DI/Lot(Batch): ASK-04001-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275, 10801902214338/33F24F0787, 33F24L0304, 33F25A0242, 33F25C0268, 33F25D0470, 33F25E0537, 33F25E0854, 33F25J0365, 33F25M0247, 33F26A1555, 33F26B0855, 33F26C0742, 33F24K0672; ASK-12703-WMC2/10801902193275/33F24K0493, 33F24L0305, 33F25B0156, 33F25E0593, 33F25H0483, 33F25J0367, 33F25M0218, 33F24K0545; ASK-15703-LMDT1/10801902193275/33F24J0164, 33F24L0307, 33F25B0192, 33F25C0230; ASK-15703-LMDTG1/10801902193275/33F25D0537, 33F25E0670, 33F25G0295, 33F25J0146, 33F25K0093, 33F25M0138, 33F26B0131, 33F25E0312; ASK-15703-PVH/10801902133226, 10801902193275, 10801902210217/33F24D0809, 33F24F0669, 33F24K0462, 33F24L0226, 33F25A0167, 33F25B0193, 33F25B0547, 33F25D0265, 33F25D0653, 33F25G0169, 33F25G0404, 33F25J0369, 33F26A1459, 33F24M0270; ASK-24301-JHH1/10801902193275, 10801902214819, 10801902210217/33F25A0170, 33F25B0552, 33F25E0547, 33F25G0222, 33F25L0056, 33F26B0421, 33F24E0546; CDC-24306-1A/30801902116919, 10801902193275, 30801902116919/33F24D0786, 33F24E0620, 33F24F0926, 33F24K0446, 33F24L0990, 33F25A0310, 33F25D0495, 33F25E0880, 33F25J0323, 33F26B0377, 33F26C0693, 33F24L1111; CDC-24703-X1A/10801902193275/33F25D0497, 33F25E0748, 33F25G0318, 33F25H0570, 33F25J0325, 33F26A1563, 33F25B0619; CDC-25123-1A/10801902193275, 10801902191622/33F24H0012, 33F24L0481, 33F25C0445, 33F25D0500, 33F25F0382, 33F25G0258, 33F26A1560, 33F26B0394, 33F25B0675; ASK-42802-ECL3/10801902193275/33F25E0567, 33F25F0128, 33F25H0464, 33F25J0286, 33F26A1399; ASK-42703-ACH/10801902193275, 30801902119514/33F24L0327, 33F24L1064, 33F25C0292, 33F25E0675, 33F25H0420, 33F25J0267, 33F25L0122, 33F25M0091, 33F26A1505, 33F24D0032; ASK-42703-BJC1/10801902193275, 10801902202519/33F24K0500, 33F24L0328, 33F25B0556, 33F25G0173, 33F25J0268, 33F26A1513, 33F26B0767, 33F25C0744; ASK-42703-DU1/10801902193275, 1080190216099/33F25B0141, 33F25C0232, 33F25E0786, 33F25J0105, 33F25M0014, 33F26C0342, 33F24F0060; ASK-42703-EMC/10801902160475, 10801902118421/33F24F0881, 33F25A0214, 33F25C0293, 33F25D0596, 33F25H0632, 33F25M0115, 33F26C0343, 33F24F0132; ASK-42703-LMDT1/10801902205657, 10801902193275/33F24F0688, 33F24J0157, 33F24L0228, 33F24L0329, 33F24L1096, 33F25A0252, 33F25B0557, 33F25C0352, 33F25E0557, 33F25E0722, 33F25G0400, 33F25K0139, 33F26A1370, 33F26B0210, 33F25C0294; ASK-42703-LMDTG1/10801902193275, 10801902205695, 10801902220896/33F25E0558, 33F25E0860, 33F25G0271, 33F25G0399, 33F25H0419, 33F26B0387, 33F24G0070; ASK-42703-MCY1/10801902193275, 0801902220896/33F24H0198, 33F24K0425, 33F25A0198, 33F25B0651, 33F25C0353, 33F25D0405, 33F25E0676, 33F25H0452, 33F25J0220, 33F25M0183, 33F26A1479, 33F26B0863, 33F25H0409; ASK-42703-NS1/10801902193275, 10801902216479/33F25A0300, 33F25B0652, 33F25C0375, 33F25E0723, 33F25H0459, 33F25J0221, 33F26A1579, 33F26B0825, 33F25C0354; ASK-42703-PAGP1/10801902193275, 10801902158717, 10801902136685/33F25D0406, 33F25E0560, 33F25E0790, 33F25H0560, 33F25L0114, 33F26A1353, 33F26A1506, 33F26B0751, 33F24D0181; ASK-42703-PAM1/10801902136685, 10801902193275/33F24E0310, 33F24L0895, 33F25A0256, 33F25B0496, 33F25C0477; ASK-42703-PAMC2/10801902193275, 10801902217131/33F25F0188, 33F25J0270, 33F26C0161, 33F24K0400; ASK-42703-PAU1/10801902193275/33F24L0414, 33F25B0143, 33F25C0474, 33F25G0397, 33F25M0313, 33F26A1349, 33F25B0232; ASK-42703-PB1/10801902193275, 10801902220377/33F25E0458, 33F25K0427, 33F24F0065; ASK-42703-PBSWH2/10801902220377, 10801902193275, 10801902220377, 10801902203189/33F24F0651, 33F24K0368, 33F24L0230, 33F24L0415, 33F24L1079, 33F25B0167, 33F25C0440, 33F25D0539, 33F25E0014, 33F25E0596, 33F25G0205, 33F25H0511, 33F25J0222, 33F25K0112, 33F25M0394, 33F26B0412, 33F24D0720; ASK-42703-PCAM1/10801902203189, 10801902193275, 10801902141030/33F24F0675, 33F24L1058, 33F25B0560, 33F25C0355, 33F25D0351, 33F25E0725, 33F25G0366, 33F25J0386, 33F25M0388, 33F26B0791, 33F24F0874; ASK-42703-PCSJ2/10801902193275, 10801902211672/33F25H0468, 33F25J0271, 33F26B0389, 33F26C0179, 33S24L0906, 33F25B0445; ASK-42703-PECL2/10801902193275/33F25H0466, 33F25J0272, 33F26A0011; ASK-42703-PGM4/10801902193275, 10801902221824/33F25B0653, 33F25D0541, 33F25J0106, 33F25J0387, 33F25K0140, 33F26B0749, 33F26C0027, 33F25E1195; ASK-42703-PHHN1/10801902193275, 10801902144734/33F25H0486, 33F25K0064, 33F25M0673, 33F26A0249, 33F26B0906, 33F25E0009; ASK-42703-PLC/10801902193275/33F25D0407, 33F25E0791, 33F25F0099, 33F25H0606, 33F26A1393, 33F25E1196; ASK-42703-PMEM/10801902193275, 10801902142167/33F25G0554, 33F25K0054, 33F25L0256, 33F26C0050, 33F24L0418; ASK-42703-PMHC1/10801902193275/10801902135244/33F25E0561, 33F25H0430, 33F25H0638, 33F25J0388, 33F25M0232, 33F26B0135, 33F26B0796, 33F25F0363; ASK-42703-PNHS1/10801902193275, 10801902225495/33F25D0542, 33F25E0599, 33F25H0498, 33F25H0650, 33F26D0066; ASK-42703-POHU2/10801902193275, 10801902212020/33F25E0562, 33F25G0284, 33F25J0389, 33F26A1421, 33F24F0662; ASK-42703-POSU2/10801902193275/33F24K0401, 33F24L0419, 33F24L0949, 33F25B0446, 33F25D0758; ASK-42703-PTJH/10801902193275, 10801902219012/33F24L0190, 33F25A0015, 33F25B0366, 33F25C0658, 33F25E0316, 33F24E0660; ASK-42703-PUCH2/10801902219012, 10801902193275, 10801902219012, 10801902135022/ ASK-42703-PUCI1/33F24F1025, 33F24L0336, 33F24L1009, 33F25B0476, 33F25C0356, 33F25E0021, 33F25F0189, 33F25H0455, 33F25J0275, 33F25K0142, 33F25M0120, 33F26A1518, 33F26B0182, 33F26B0781, 33F24F0850; ASK-42703-PUHC2/10801902193275, 10801902159608/33F25D0353, 33F25E0602, 33F25G0288, 33F25H0635, 33F25J0277, 33F25K0143, 33F26B0386, 33F26C0149, 33F24D0765; ASK-42703-PUMH/10801902129465, 10801902193275, 10801902159592/33F24F0697, 33F24K0709, 33F24L0997, 33F25C0301, 33F25E0677, 33F25J0278, 33F26A0256, 33F26B0789, 33F26C0227, 33F24D0698; ASK-42703-PUPM1/10801902159592, 10801902193275, 10801902225150/33F24F0761, 33F24K0499, 33F24L1074, 33F25B0519, 33F25C0357, 33F25D0354, 33F25D0598, 33F25E0678, 33F25G0346, 33F25J0279, 33F25M0126, 33F26B0363; ASK-42703-SHUF2/10801902193275, 10801902208368/33F25D0355, 33F25E0792, 33F25H0473, 33F25J0280, 33F25M0204, 33F26A1501, 33F26B0832, 33F24L0339; ASK-42703-SL1/10801902193275, 10801902205206/33F25B0483, 33F25C0443, 33F25D0482, 33F25E0793, 33F25G0306, 33F25J0281, 33F26A1437, 33F24D0631; ASK-42703-UMC/10801902193275, 10801902205206/33F24K0363, 33F24L0340, 33F25B0568,33F25E0801, 33F25G0328, 33F25J0282, 33F25M0194, 33F26A1444, 33F26B0769, 33F26C0221, 33F25B0158; ASK-42703-WHH/10801902193275, 10801902159189, 30801902119576/33F25E0565, 33F25G0350, 33F25J0283, 33F26B0777, 33F24E0552; ASK-42802-CHM/10801902193275/33F24H0178, 33F24K0480, 33F24L0859, 33F25D0236, 33F25F0190, 33F25H0518, 33F25J0284, 33F25M0139, 33F26B0175, 33F25E0005; ASK-42802-LMDT1/10801902205664, 10801902193275/33F24F0737, 33F24K0381, 33F24L0250, 33F24L0423, 33F25B0570, 33F25C0377, 33F25F0129, 33F25G0281, 33F25J0158, 33F25K0146, 33F26C0156, 33F25F0533; ASK-42802-MCY1/10801902193275, 10801902220384/33F24K0328, 33F24K0754, 33F24F0964; ASK-42802-PBSWH2/10801902193275, 10801902220384/33F24H0200, 33F24K0408, 33F24L0424, 33F24L1006, 33F25B0477, 33F25D0357, 33F25G0203, 33F25G0204, 33F25H0659, 33F25J0390, 33F25M0195, 33F25M0335, 33F26B0424, 33F24F0759; ASK-42802-POSU2/10801902193275/33F24K0473, 33F25D0759; ASK-42802-PUNCC2/10801902164251, 10801902193275, 10801902159585/33F24F0948, 33F24L0425, 33F25H0443, 33F25J0394, 33F24D0660; ASK-42802-PUPM1/10801902159585, 10801902193275, 10801902225143/33F24F0668, 33F24K0422, 33F24L0341, 33F24L1042, 33F25C0305, 33F25E0679, 33F25F0194, 33F25J0159, 33F25M0123, 33F26B0364; ASK-42802-TGH1/10801902213829, 10801902193275, 10801902213829/33F24L1054, 33F25B0521, 33F25D0311, 33F25E0604, 33F25G0225, 33F25J0288, 33F25L0204, 33F26A1543, 33F26B0844, 33F26C0224, 33F25C0306; ASK-42854-BJC1/10801902202540, 10801902193275, 10801902202540/33F24F0644, 33F24K0348, 33F24L0232, 33F25A0260, 33F25B0571, 33F25D0358, 33F25D0601, 33F25E0863, 33F25G0367, 33F26A1524, 33F26B0764, 33F26C0140, 33F24H0126; ASK-42854-PBMH/10801902193275, 40801902131469/33F26A0241, 33F24E0639; ASK-42854-PMM/40801902131469, 10801902193275/33F24F1014, 33F24L1013, 33F25C0307, 33F25D0546, 33F25E0802, 33F25H0480, 33F25J0398, 33F25A0019; ASK-42854-PUCH2/10801902193275, 10801902219050/33F25K0065, 33F26B0902, 33F24L0347; ASK-45703-ACH/10801902193275, 10801902203257, 30801902119644/33F25B0235, 33F25E0007, 33F25F0237, 33F25K0046, 33F25M0675, 33F26B0221, 33F24D0033; ASK-45703-ARM/10801902193275, 1080190215812/33F24L0903, 33F25B0449, 33F25D0363, 33F25E0682, 33F25H0479, 33F25J0228, 33F25K0150, 33F26A1423, 33F26B0849, 33F25F0004; ASK-45703-BJC1/10801902193275, 10801902202533, 10801902213782/33F24K0426, 33F24L0826, 33F25B0450, 33F25B0577, 33F25D0547, 33F25F0104, 33F25F0199, 33F25M0096, 33F26A1348, 33F26B0378, 33F26B0750, 33F24F0776; ASK-45703-BLH/10801902193275, 10801902213782, 10801902135381/33F24L1067, 33F25J0110, 33F25K0071, 33F25K0151, 33F25M0331, 33F26A1457, 33F26B0776, 33F24F0165; ASK-45703-DU1/10801902193275, 10801902160970, 10801902160468/33F25B0451, 33F25D0548, 33F25E0683, 33F25H0558, 33F26A1451, 33F26B0208, 33F26B0707, 33F26B0845, 33F24D0579; ASK-45703-HHC4/10801902193275, 10801902211467, 10801902205671/33F25D0364 ,33F25D0661, 33F25E0867, 33F25G0246, 33F25H0598, 33F25J0229, 33F25M0152, 33F26A1537, 33F26B0818, 33S25E0867, 33F24F0873; ASK-45703-LMDT1/10801902193275, 10801902205671/33F24K0440, 33F24L0432, 33F24L0919, 33F25B0160, 33F25D0365, 33F25D0603, 33F25E0608, 33F25G0326, 33F25H0475, 33F25J0230, 33F25M0153, 33F26A1552, 33F26B0880, 33F25B0453; ASK-45703-LMDTG1/10801902193275, 10801902205749, 10801902220902/33F25B0579, 33F25E0018, 33F25E0609, 33F25F0200, 33F25G0398, 33F25J0401, 33F25M0190, 33F25M0332, 33F26B0482, 33F26C0226, 33F24G0072; ASK-45703-MCY1/10801902193275/33F24J0132, 33F24K0445, 33F24L0433, 33F24L1028, 33F25B0657, 33F25E0022, 33F25E0610, 33F25F0201, 33F25H0657, 33F25M0144, 33F26A1573, 33F25L0143; ASK-45703-NO/10801902205213, 10801902193275, 10801902216417/33F24F0844, 33F24L0352, 33F25B0581, 33F25E0611, 33F24D0769; ASK-45703-NS1/10801902216417, 10801902193275, 10801902216417/33F24F0835, 33F24L0434, 33F24L1047, 33F25E0612, 33F25F0130, 33F25G0214, 33F25M0176, 33F26A1544, 33F26B0864, 33F25F0006; ASK-45703-PADV1/10801902193275/33F24J0146, 33F24K0458, 33F24L0353, 33F25C0311, 33F25E0423, 33F25E0684, 33F25H0561, 33F25M0127, 33F26A0775, 33F25A0265; ASK-45703-PAGP1/10801902193275, 10801902158724/33F25E0613, 33F25F0202, 33F25G0409, 33F25J0297, 33F26A1339, 33F26C0125, 33F25B0658; ASK-45703-PAMC1/10801902193275, 10801902217148, 10801902208344/33F25D0549, 33F25E0728, 33F25J0298, 33F25K0152, 33F26B0199, 33F24D0738; ASK-45703-PAU1/10801902208344, 10801902193275, 10801902220353/33F24F0783, 33F24L0354, 33F25D0483, 33F25E0729, 33F25H0534, 33F25J0404, 33F24F0070; ASK-45703-PBSWH2/10801902220353, 10801902193275, 10801902220353, 10801902203158/33F24F0937, 33F24L0437, 33F24L1112, 33F25A0306, 33F25B0659, 33F25E0614, 33F25E0803, 33F25F0080, 33F25H0368, 33F25H0513, 33F25K0153, 33F25M0191, 33F26C0157, 33F24F0660; ASK-45703-PCAM1/10801902193275/33F24L0355, 33F25C0312, 33F25E0016, 33F25E0804, 33F25J0162, 33F26A1447, 33F24K0479; ASK-45703-PCSJ2/10801902193275, 10801902211689, 10801902202861/33F25G0245, 33F25J0165, 33F25K0155, 33F26A1546, 33F26B0853, 33F24D0896; ASK-45703-PDM1/10801902202861, 10801902193275/33F24F0747, 33F25A0268, 33F25B0584, 33F25D0368, 33F25D0604, 33F25E0617, 33F25G0330, 33F25H0612, 33F25J0166, 33F25M0196, 33F26A1460, 33F25B0585; ASK-45703-PECL2/10801902193275/33F25D0369, 33F25D0605, 33F25E0619, 33F25G0242, 33F25J0168, 33F26A0013; ASK-45703-PGM4/10801902193275, 10801902221817/33F25B0660, 33F25D0412, 33F25J0169, 33F25K0078, 33F26C0176, 33F24M0174; ASK-45703-PGVH/10801902193275, 10801902200508/33F25E0310, 33F25H0781, 33F24F0101; ASK-45703-PHF4/)10801902200508, 10801902193275/33F24F0887, 33F24L0253, 33F24L0439, 33F25A0269, 33F25B0586, 33F25C0314, 33F25D0606, 33F25E0575, 33F25F0118, 33F25M0060, 33F25M0170, 33F26A1480,...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 24, 2026
Recall initiation date: Apr 21, 2026
Center classification date: Jun 12, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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