{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89735",
      "recalling_firm": "Kaneka America Corp",
      "address_1": "546 5th Ave Fl 21",
      "address_2": "N/A",
      "postal_code": "10036-5000",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US only: CA, NH, CT, MA, FL, DE, NY, NJ, PA, OH, MD, VA, NC, SC, GA, MS, TN, TX, IN, AZ, MI, WI, MN, IL, MO, NE, CO, WA, OR, UT, KS, OK, AL, ME",
      "recall_number": "Z-0900-2022",
      "product_description": "LIPOSORBER System, Model: LA-15, consisting of:     Apheresis machine, product# 101445 model: MA-03, and     disposables (product#, model)   [#101447, KP-05 Sulflux Plasma Separator],   [#101473, HDE KP-05 Sulflux Plasma Separator],   [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)],   [#101786, NK-M3R(UL) Tubing (Luer Lock Type)],   [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)],   [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)].     Associated labeling:        1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS,  2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS     3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS",
      "product_quantity": "138 Systems, 54703 disposables",
      "reason_for_recall": "Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.",
      "recall_initiation_date": "20220217",
      "center_classification_date": "20220408",
      "termination_date": "20240506",
      "report_date": "20220420",
      "code_info": "All product lot and UDI numbers are affected."
    }
  ]
}