Recall archive / FDA device enforcement

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 ... — FDA record Z-2388-2026

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: 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 KI...
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: 62,719
Agency-reported status: Ongoing
Source record identifier: Z-2388-2026

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): 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

Label field

Details supplied by the agency

Lot, code or applicability

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

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

Related records