{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "221952",
      "product_res_number": "Z-3133-2026",
      "event_date_initiated": "2026-08-05",
      "event_date_posted": "2026-09-10",
      "recall_status": "Open, Classified",
      "res_event_number": "99573",
      "product_code": "KPO",
      "k_numbers": [
        "K012547"
      ],
      "product_description": "MedicaLyte Liquid Bicarbonate Concentrate\r\n\r\nREF: BC-100 and BC+201",
      "code_info": "BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026)\nBC+201- Lot: N4L010(exp.11/06/2026)",
      "firm_fei_number": "1000142899",
      "recalling_firm": "Nipro Renal Soultions USA, Corporation",
      "address_1": "509 Fishing Creek Rd",
      "city": "Lewisberry",
      "state": "PA",
      "postal_code": "17339-9517",
      "additional_info_contact": "Jessica Oswald-McLeod\n305-432-6699",
      "reason_for_recall": "Hemodialysis concentrates contain high endotoxin levels",
      "root_cause_description": "Process control",
      "action": "On August 6, 2026 Nipro Medical Corporation issued  a Urgent Medical Device Recall notification via Email. Nipro asked consignees to take the following actions:\n\n1.\tImmediately examine your inventory for the affected product codes and lot numbers listed on the Recall response form.\n2.\tImmediately segregate, quarantine, and discontinue use or distribution of any affected product in your possession.\n3.\tDo not use, sell, transfer, or distribute affected products.\n4.\tComplete the enclosed Recall Response Form within 10 business days, even if you do not have affected product on hand.\n5.\tContact Nipro customer service  for product return and credit, if applicable.\n6.\tIf you distributed affected product, promptly notify your customers, provide them with a copy of this recall notice, and request that they complete and return the response form or equivalent confirmation.\n\n7. Product Return or Disposition: Affected products should remain quarantined until return, destruction, or other documented disposition instructions are provided by Nipro. Please retain all documentation related to product quarantine, return, destruction, or other disposition for recall reconciliation.",
      "product_quantity": "3,286 cases",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.",
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        "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5820",
        "device_class": "2",
        "registration_number": [
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