{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Morrisville",
      "state": "NC",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98793",
      "recalling_firm": "ARROW INTERNATIONAL, LLC",
      "address_1": "3015 Carrington Mill Blvd",
      "address_2": "",
      "postal_code": "27560-5437",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-2371-2026",
      "product_description": "Description/REF:  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1;  EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501;  EPIDURAL CATHETERIZATION KIT/AK-05502;  EPIDURAL CATHETERIZATION KIT/AK-05502D;  EPIDURAL CATHETERIZATION KIT/AK-05503;  EPIDURAL CATHETERIZATION KIT/AK-05503-L;  SPINAL ANES/EPIDURAL CATH KIT/AK-05560;  SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1;  EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1;  EPIDURAL CATHETERIZATION KIT/ASK-05400-GH;  SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC;  EPIDURAL CATHETERIZATION KIT/ASK-05401-NM;  SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1;  EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1;  EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1;  EPIDURAL CATHETER KIT: 19GA X 90CM\tASK-05500-MVH;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC;  19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH;  SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1;  SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2;  SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1;  EPIDURAL CATHETERIZATION KIT/ASK-17019-SM;  EPIDURAL CATHETERIZATION KIT/BP-05501;  EPIDURAL CATHETERIZATION KIT/CK-05401;  EPIDURAL CATHETERIZATION KIT/HS-05501;  EPIDURAL CATHETERIZATION KIT/MM-05501;  EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK;  EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD;  EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL;  EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH;  EPIDURAL CATHETERIZATION KIT/NM-05401;  EPIDURAL CATHETERIZATION KIT/SJ-05501;  EPIDURAL CATHETERIZATION KIT/SM-05401;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401;  EPIDURAL CATHETERIZATION KIT/TM-05502;  SPINAL ANES/EPIDURAL CATH KIT/UI-05502;  SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM;  EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR;  EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM;  EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1;  EPIDURAL CATHETERIZATION KIT/ASK-05501-GH;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM;  EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM;  EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1;  EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1;  EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1;  SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2;  EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP;  EPIDURAL CATHETERIZATION KIT/MH-05503-1;    EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2;  Epidural Catheterization Kit: 19GA/ASK-05500-SC1;  Epidural Catheterization Kit: 19GA/ASK-05500-SC3;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1;  EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC;  EPIDURAL CATHETERIZATION KIT/ASK-05502-NY;  EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH",
      "product_quantity": "1,525,831",
      "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.",
      "recall_initiation_date": "20260421",
      "center_classification_date": "20260612",
      "report_date": "20260624",
      "code_info": "REF(Material)/UDI-DI/Lot(Batch): ASK-05502-VM1/10801902210217, 10801902209938/33F25C0168, 33F25C0880, 33F25E0202, 33F25G0134, 33F25H0126, 33F26C0297, 33F24C0216;  AK-05501/)10801902210217, 10801902209501, 10801902209518/33F24E0057, 33F24E0058, 33F24J0496, 33F24K0094, 33F24L0564, 33F25A0460, 33F25A0617, 33F25C0728,33F25E0043, 33F25E0913, 33F25G0081, 33F25H0015, 33F25J0465, 33F25J0822, 33F25K0254, 33F25L0376, 33F26C0300, 33F24B0119;  AK-05502/10801902209518, 10801902210217, 10801902209525/33F24C0015, 33F24G0581, 33F24G0582, 33F24G0583, 33F24J0497, 33F24J0678, 33F24J0679, 33F24J0680, 33F24J0681, 33F24K0095, 33F24K0310, 33F24L0580, 33F24L0624, 33F24L0628, 33F24L0630, 33F24L0757, 33F24L0785, 33F25A0461, 33F25A0618, 33F25A0619, 33F25A0620, 33F25C0103, 33F25C0724, 33F25C0725, 33F25C0741, 33F25C0791, 33F25E0044, 33F25E0291, 33F25E0292, 33F25E0293, 33F25E0914, 33F25E1067, 33F25G0082, 33F25G0159, 33F25H0016, 33F25H0197, 33F25H0198, 33F25H0199, 33F25J0466, 33F25J0643, 33F25J0790, 33F25J0805, 33F25J0806, 33F25J0807, 33F25J0808, 33F25K0024, 33F25K0252, 33F25K0358, 33F25K0359, 33F25L0099, 33F25L0266, 33F25L0267, 33F25M0970, 33F25M0978, 33F26A1100, 33F24C0096;  AK-05502D/10801902210217, 10801902209532/33F24G0331, 33F24J0498, 33F24K0096, 33F24L0713, 33F25A0462, 33F25C0745, 33F25E0045, 33F25H0017, 33F25J0467, 33F25L0366, 33F24C0017;  AK-05503/10801902210217, 10801902209549/33F24J0277, 33F24J0499, 33F24K0097, 33F24L0674, 33F25A0463, 33F25C0949, 33F25E0046, 33F25E0915, 33F25H0018, 33F25J0823, 33F25L0406, 33F25M0912, 33F24C0018;  AK-05503-L/10801902209549, 10801902210217, 10801902209549/33F24C0019, 33F24E0066, 33F24J0682, 33F24K0098, 33F24L0613, 33F24L0758, 33F25A0464, 33F25C0104, 33F25C0731, 33F25C0793, 33F25E0047, 33F25E0916, 33F25G0083, 33F25H0019, 33F25H0200, 33F25J0791, 33F25J0809, 33F25K0026, 33F25K0253, 33F25L0057, 33F25L0352, 33F25M0861, 33F26A0989, 33F24J0278;  AK-05560/10801902210217, 10801902209556, 30801902121722/33F24J0501, 33F24K0099, 33F24L0552, 33F25A0145, 33F25A0465, 33F25C0743, 33F25E0048, 33F25E0917, 33F25G0084, 33F25H0020, 33F25J0737, 33F25J0824, 33F25M0895, 33F26B0538, 33F26C0592, 33F24A0812;  ASK-02520-SBMC1/10801902209570, 10801902210217, 10801902193275/33F24D0103, 33F24F0275, 33F24G0396, 33F25A0137;  ASK-05400-BW1/10801902209617, 10801902209631/33F24D0153, 33F24E0474, 33F24G0461, 33F24J0307, 33F24L0556, 33F25B0246, 33F25C0729, 33F25E0178, 33F25G0121, 33F25J0899, 33F25L0042, 33F25L0450, 33F24C0196;  ASK-05400-GH/10801902209631, 10801902210217, 10801902202199/33F24D0154, 33F24E0480, 33F24G0292, 33F24J0310, 33F24J0600, 33F24L0597, 33F25A0153, 33F25C0161, 33F25C0754, 33F25E0181, 33F25G0123, 33F25J0532, 33F25L0391, 33F25M0897, 33F24D0155;  ASK-05401-LMC/10801902210217, 10801902209662/33F24J0603, 33F25F0240, 33F25G0754, 33F25J0534, 33F24D0031;  ASK-05401-NM/10801902210217/33F24E0104, 33F24G0295, 33F24J0311, 33F24J0604, 33F24K0223, 33F24L0559, 33F25A0548, 33F25C0840, 33F25E0184, 33F25G0125, 33F25H0113, 33F25J0535, 33F25L0024, 33F25L0361, 33F24E0027;  ASK-05500-BID1/10801902210217/33F24E0490, 33F24G0297, 33F24H0488, 33F24J0607, 33F24L0594, 33F25A0551, 33F25C0823, 33F25E0187, 33F25G0127, 33F25J0536, 33F25L0438, 33F24K0228;  ASK-05500-JHH1/10801902210217, 10801902209716, 10801902209723/33F24L0572, 33F25B0379, 33F25D0215, 33F25E0190, 33F25G0129, 33F25H0744, 33F25J0538, 33F25K0407, 33F25M0955, 33S24L0572, 33F24C0203;  ASK-05500-MCV1/10801902210217/33F24E0494, 33F24E0495, 33F24G0470, 33F24J0611, 33F24K0229, 33F24L0707, 33F25A0554, 33F25C0784, 33F25E0191, 33F25E1005, 33F25G0761, 33F25H0115, 33F24E0496;  ASK-05500-MVH/10801902209730, 10801902210217/33F24D0380, 33F24E0498, 33F24G0472, 33F24L0681;  ASK-05500-UMC/10801902209754, 10801902210217/33F24D0382, 33F24J0316, 33F24K0233, 33F24L0085, 33F24L0772, 33F25C0166, 33F25C0737, 33F25E0196, 33F25E0317, 33F25E1008, 33F25H0120, 33F25J0540, 33F25L0397, 33F25M0904, 33F24E0502;  ASK-05502-MLH/10801902210217/33F24J0618, 33F24K0239, 33F24L0555, 33F25A0562, 33F25C0996, 33F25E0201, 33F25H0125, 33F25J0544, 33F25L0440, 33F26B0977, 33F24L0583;  ASK-05560-JMH1/10801902210217, 10801902209983/33F24G0483, 33F24L0773, 33F25A0566, 33F25C0894, 33F25E1014, 33F25H0130, 33F25J0548, 33F24E0519;  ASK-05560-MKD2/10801902193275, 10801902210217/33F24K0246, 33F25G0468, 33F24J0476;  ASK-05560-OM1/10801902210217, 10801902210002/33F24K0550, 33F25A0155, 33F25C0171, 33F25F0383, 33F25G0560, 33F25H0131, 33F25H0746, 33F25J0784, 33F25L0006, 33F25M0903, 33F24D0391;  ASK-17019-SM/10801902210217, 10801902211221/33F25G0137, 33F25H0136, 33F25J0553, 33F25L0465, 33F24B0348;  BP-05501/10801902210217, 10801902193275/33F24E0156, 33F24J0642, 33F24K0270, 33F25B0689, 33F25C0868, 33F25E1034, 33F25G0145, 33F25H0158, 33F25J0568, 33F25L0369, 33F26B0518, 33F25C0444;  CK-05401/10801902202144, 10801902210217, 10801902193275/33F24C0256, 33F25A0591, 33F25C0972, 33F25E0256, 33F25E1040, 33F25H0756, 33F25J0935, 33F25L0244, 33F26B0620, 33F25D0674;  HS-05501/10801902210217, 10801902202090/33F24E0580, 33F24J0329, 33F24B0389;  MM-05501/10801902210217/33F24J0655, 33F24K0287, 33F24L0788, 33F25J0628, 33F25L0445, 33F24C0263;  MP-17019-TK/10801902210217/33F24D0409, 33F24J0390, 33F24K0288, 33F24L0546, 33F25A0595, 33F25C0727, 33F25E0262, 33F25E1045, 33F25H0170, 33F25J0629, 33F25L0441, 33F25M0939, 33F24D0410;  MP-17019-TKD/10801902210217, 10801902210224/33F24J0657, 33F24L0698, 33F25C0760, 33F25E0263, 33F25H0171, 33F25J0938, 33F24B0152;  MP-17019-TKL/10801902210224, 10801902210217/33F24D0038, 33F24K0289, 33F24L0614, 33F25C0190, 33F25C0839, 33F25E0264, 33F25G0149, 33F25J0630, 33F25K0380, 33F24K0290;  MSO-05401-JMH/10801902210217/33F25C0193, 33F25H0172, 33F25J0631, 33F25L0375, 33F25M0880, 33F24D0413;  NM-05401/10801902210217, 10801902210262, 10801902140644/33F25J0944, 33F25M0968, 33F26B0600, 33F24C0780;  SJ-05501/10801902210330, 10801902210217, 10801902202496/33F24C0049, 33F24C0050, 33F24J0382, 33F24J0383, 33F24J0384, 33F24J0385, 33F24J0386, 33F24K0552, 33F24K0553, 33F24K0554, 33F24K0555, 33F24K0556, 33F24K0557, 33F24L0625, 33F24L0721, 33F24L0760, 33F24L0786, 33F25A0605, 33F25A0623, 33F25A0624, 33F25C0202, 33F25C0789, 33F25C0790, 33F25C0945, 33F25C0997, 33F25E0278, 33F25E0295, 33F25E0296, 33F25E1057, 33F25E1068, 33F25G0154, 33F25G0160, 33F25H0183, 33F25H0202, 33F25H0203, 33F25J0639, 33F25J0644, 33F25J0798, 33F25J0811, 33F25J0812, 33F25J0813, 33F26B0601, 33F26C0299, 33F26C0307, 33F24A1336;  SM-05401/10801902210217, 10801902210354, 10801902193275/33F24G0561, 33F24K0302, 33F24L0607, 33F25C0204, 33F25C0805, 33F25E0279, 33F25E1058, 33F25H0184, 33F25J0948, 33F26A1030, 33F24G0270;  TM-05401/10801902210217, 30801902202155, 10801902210361/33F24D0418, 33F24G0563, 33F24J0669, 33F24L0089, 33F24L0741, 33F25C0207, 33F25C0918, 33F25E0282, 33F25E1059, 33F25J0950, 33F25L0447, 33F26C0308, 33F24B0410;  TM-05502/10801902210378/33F24B0411;  UI-05502/10801902210217/33F24G0565, 33F24J0670, 33F24L0562, 33F25A0607, 33F25C0881, 33F25E0283, 33F25E1060, 33F25G0752, 33F25H0186, 33F25J0951, 33F24A0359;  ASK-05400-SHM/10801902210217/33F24E0482, 33F24G0465, 33F24J0601, 33F24K0221, 33F24L0800, 33F25C0162, 33F25C0888, 33F25E0182, 33F25H0741, 33F25L0457, 33F24E0483;  ASK-05400-UOM/10801902210217/33F25G0124, 33F25H0742, 33F25K0263, 33F24G0294;  ASK-05500-MR/10801902210217, 10801902209730/33F24E0497, 33F24G0471, 33F24K0230, 33F25A0555, 33F25C0796, 33F25E0192, 33F25H0116, 33F25K0408, 33F25M0854, 33F24C0204;  ASK-05500-TM/10801902210217, 10801902209747, 10801902209754/33F25C0165, 33F25E1007, 33F25M0871, 33F26C0256, 33F24C0206;  ASK-05501-BHL1/10801902210217/33F24L0566, 33F25A0558, 33F25C0810, 33F25E0197, 33F25E1009, 33F25H0121, 33F25J0541, 33F25L0439, 33F24E0503;  ASK-05501-GH/10801902210217, 10801902210392/33F24K0235, 33F25A0559, 33F25E0198, 33F25H0122, 33F25J0542, 33F24D0384;  ASK-05501-SM/10801902210217, 10801902210392, 10801902214857/33F24E0505, 33F24K0236, 33F25A0560, 33F25C0808, 33F25E0199, 33F25E1010, 33F25H0123, 33F25J0907, 33F26C0304, 33F24C0210;  ASK-05502-BSM/10801902209853, 10801902210217/33F24D0385, 33F24E0508, 33F24G0301, 33F24K0237, 33F25A0154, 33F25B0687, 33F25H0124, 33F25J0543, 33F25K0409, 33F25L0466, 33F26B0592, 33F24E0509;  ASK-05502-MGH1/10801902210217, 10801902209860/33F24J0617, 33F24L0569, 33F25B0247, 33F25C0938, 33F25E0304, 33F25G0133, 33F25J0909, 33F25L0098, 33F26B0545, 33F24J0318;  ASK-05503-BWB1/10801902210217, 10801902209938, 10801902209952/33F24E0514, 33F24G0481, 33F24J0619, 33F24K0241, 33F24L0690, 33F25C0169, 33F25C0756, 33F25E1011, 33F25J0545, 33F25L0453, 33F26B0584, 33F24C0217;  ASK-05503-HMH/10801902210217, 10801902209952, 10801902209969/33F24L0643, 33F25A0563, 33F25C0170, 33F25C0765, 33F25E1012, 33F25G0135, 33F25H0127, 33F25J0546, 33F25L0451, 33F26A1079, 33F24C0218;  ASK-05503-SPH/10801902210217, 10801902209969, 10801902211405/33F24E0516, 33F24J0620, 33F24K0243, 33F24L0598, 33F25A0564, 33F25E0204, 33F25L0458, 33F25M0951, 33F24C0219;  ASK-05503-UPM1/10801902211405, 10801902210217, 10801902209976/33F24D0389, 33F24E0160, 33F24J0621, 33F24K0244, 33F24L0549, 33F25A0565, 33F25C0992, 33F25E0205, 33F25E1013, 33F25H0129, 33F25J0547, 33F25L0454, 33F24D0390;  ASK-05560-UCI2/10801902210217, 10801902193275/33F24G0485, 33F24J0623, 33F24L0593, 33F25A0567, 33F25C0893, 33F25E0206, 33F25E1015, 33F25H0132, 33F25J0911, 33F25L0061;  ASK-17019-UMP/10801902210217, 10801902211221, 10801902210057/33F24J0628, 33F24K0250, 33F25B0694, 33F25E0216, 33F25H0137, 33F25J0916, 33F26B1000, 33F24B0350;  MH-05503-1/10801902210217/33F25H0169, 33F24G0542  ASK-05401-VB2/10801902214840/33F24C0199, 33F24D0374, 33F24E0486, 33F24G0296, 33F24J0312, 33F24J0605, 33F24K0224, 33F24L0733, 33F25A0549;  ASK-05500-SC1 /10801902202250/33F24B0319, 33F24C0205, 33F24D0381, 33F24E0499, 33F24G0299, 33F24J0315, 33F24J0613, 33F24K0232, 33F24L0567, 33F25A0557, 33F25C0884, 33F25E0194;  ASK-05500-SC3/10801902223651/33F25G0751, 33F25H0118, 33F26B0644;  ASK-05501-AFH1/10801902209761/33F24G0475;  ASK-05501-BMC/10801902209785/33F24J0479;  ASK-05502-NY/10801902209884/33F24E0512;  ASK-17019-RMH/10801902214918/33F24B0346, 33F24E0531",
      "more_code_info": ""
    }
  ]
}