{
  "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:  133FV-11         10888628003927,  133FV-12 10888628003934,  133FV-13 10888628003941,  133FV-14 10888628003958,  133FV-15 10888628003965,  133FV-16 10888628003972;    STYLE 133MV:  133MV-11 10888628004108,  133MV-12 10888628004115,  133MV-13 10888628004122,  133MV-14 10888628004139,  133MV-15 10888628004146,  133MV-16 10888628004153;    STYLE 133LV:  133LV-11 10888628004047,  133LV-12 10888628004054,  133LV-13 10888628004061,  133LV-14 10888628004078,  133LV-15 10888628004085,  133LV-16 10888628004092;    STYLE 133FX:    133FX-11 10888628003989,  133FX-12 10888628003996,  133FX-13 10888628004009,  133FX-14 10888628004016,  133FX-15 10888628004023,  133FX-16 10888628004030;    STYLE 133MX:  133MX-11 10888628004160,  133MX-12 10888628004177,  133MX-13 10888628004184,  133MX-14 10888628004191,  133MX-15 10888628004207,  133MX-16 10888628004214;    STYLE 133SX:  133SX-11 10888628003804,  133SX-12 10888628003811,  133SX-13 10888628003828,  133SX-14 10888628003835,  133SX-15 10888628003842,  133SX-16 10888628003859;    STYLE 133SV:  133SV-11 10888628003866,  133SV-12 10888628003873,  133SV-13 10888628003880,  133SV-14 10888628003897,  133SV-15 10888628003903,  133SV-16 10888628003910;",
      "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 (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers:    STYLE 133FV:  133FV-11,  133FV-12,  133FV-13,  133FV-14,  133FV-15,  133FV-16;    STYLE 133MV:  133MV-11,  133MV-12,  133MV-13,  133MV-14,  133MV-15,  133MV-16;      STYLE 133LV:  133LV-11,  133LV-12,  133LV-13,  133LV-14,  133LV-15,  133LV-16;      STYLE 133FX:  133FX-11  133FX-12  133FX-13  133FX-14  133FX-15  133FX-16    STYLE 133MX:  133MX-11,  133MX-12,  133MX-13,  133MX-14,  133MX-15,  133MX-16;      STYLE 133SX:  133SX-11,  133SX-12,  133SX-13,  133SX-14,  133SX-15,  133SX-16;      STYLE 133SV:  133SV-11,  133SV-12,  133SV-13,  133SV-14,  133SV-15,  133SV-16;    These products may have been sold under the McGhan, Inamed or NATRELLE brands.      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-2455-2019",
      "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"
    }
  ]
}