{
  "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": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "2525 Dupont Dr",
      "reason_for_recall": "The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.",
      "address_2": "",
      "product_quantity": "4,026,287 Breast Implants and Tissue Expanders Combined in total",
      "code_info": "ALL LOTS;          Product Code/UDI    STYLE 133FV-T:  133FV-11-T 10888628004221,  133FV-12-T 10888628004238,  133FV-13-T 10888628004245,  133FV-14-T 10888628004252,  133FV-15-T 10888628004269,  133FV-16-T 10888628004276;    STYLE 133MV-T:  133MV-11-T 10888628004405,  133MV-12-T 10888628004412,  133MV-13-T 10888628004429,  133MV-14-T 10888628004436,  133MV-15-T 10888628004443,  133MV-16-T 10888628004450;      STYLE 133LV-T:  133LV-11-T 10888628004344,  133LV-12-T 10888628004351,  133LV-13-T 10888628004368,  133LV-14-T 10888628004375,  133LV-15-T 10888628004382,  133LV-16-T 10888628004399;      STYLE 133FX-T:  133FX-11-T 10888628004283,  133FX-12-T 10888628004290,  133FX-13-T 10888628004306,  133FX-14-T 10888628004313,  133FX-15-T 10888628004320,  133FX-16-T 10888628004337;    STYLE 133MX-T:  133MX-11-T 10888628004467,  133MX-12-T 10888628004474,  133MX-13-T 10888628004481,  133MX-14-T 10888628004498,  133MX-15-T 10888628004504,  133MX-16-T 10888628004511;    STYLE 133SX-T:  133SX-11-T 10888628004580,  133SX-12-T 10888628004597,  133SX-13-T 10888628004603,  133SX-14-T 10888628004610,  133SX-15-T 10888628004627,  133SX-16-T 10888628004634;    STYLE 133SV-T:  133SV-11-T 10888628004528,  133SV-12-T 10888628004535,  133SV-13-T 10888628004542,  133SV-14-T 10888628004559,  133SV-15-T 10888628004566  133SV-16-T 10888628004573",
      "center_classification_date": "20190911",
      "distribution_pattern": "Worldwide Distribution and US Nationwide     All fifty (50) US States,  the US Virgin Islands and Puerto Rico.  (AK, AL, AR, AZ, CA,  CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY).    OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.",
      "state": "CA",
      "product_description": "Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set    STYLE 133FV-T:  133FV-11-T,  133FV-12-T,  133FV-13-T,  133FV-14-T,  133FV-15-T,  133FV-16-T;   STYLE 133MV-T:  133MV-11-T,  133MV-12-T,  133MV-13-T,  133MV-14-T,  133MV-15-T,  133MV-16-T;  STYLE 133LV-T:  133LV-11-T,  133LV-12-T,  133LV-13-T,  133LV-14-T,  133LV-15-T,  133LV-16-T;  STYLE 133SV-T:  133SV-11-T,  133SV-12-T,  133SV-13-T,  133SV-14-T,  133SV-15-T,  133SV-16-T  STYLE 133FX-T:  133FX-11-T,  133FX-12-T,  133FX-13-T,  133FX-14-T,  133FX-15-T,  133FX-16-T;    STYLE 133MX-T:  133MX-11-T,  133MX-12-T,  133MX-13-T,  133MX-14-T,  133MX-15-T,  133MX-16-T;    STYLE 133SX-T:  133SX-11-T,  133SX-12-T,  133SX-13-T,  133SX-14-T,  133SX-15-T,  133SX-16-T;      Product Usage:   intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.",
      "report_date": "20190918",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Allergan PLC",
      "recall_number": "Z-2457-2019",
      "initial_firm_notification": "Press Release",
      "product_type": "Devices",
      "event_id": "83500",
      "more_code_info": "",
      "recall_initiation_date": "20190724",
      "postal_code": "92612-1531",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}