{
  "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": "Zelienople",
      "address_1": "Jackson Pointe Commerce",
      "reason_for_recall": "The surgical gowns were manufactured in a facility that is not registered by the FDA.",
      "address_2": "4050 Jacksons Pointe Ct",
      "product_quantity": "2,8,68 total kits",
      "code_info": "ACS Tray Numbers:   WXCT12E; Lot # 998201, Exp. Date 001/02/2021 (70 kits)  PTHS10C; Lot # 664191, Exp. Date 12/02/2020 (2 kits)  AVHA64H; Lot # 663191, Exp. Date 12/06/2020 (30 kits)  WXPO16G; Lot # 639191, Exp. Date 12/27/2020 (26 kits) and Lot # 689191, Exp. Date 11/07/2020 (6 kits)  VSSA12G; Lot # 646191, Exp. Date 12/20/2020 (12 kits)  AGBA20H: Lot 3 970191, Exp. Date 01/30/20 (2 kits)  WXSA12H; Lot # 653191, Exp. Date 12/13/2020 (40 kits)  WXKA26H; Lot # 981201, Exp. Date 01/19/2021 (18 kits) and Lot # 639191, Exp. Date 12/27/2020 (32 kits)  WXHA64H; Lot # 682191, Exp. Date 11/14/2020 (18 kits); Lot # 636191, Exp. Date 12/30/2020 (121 kits) and Lot # 684191, Exp. Date 11/12/2020 (6 kits)  AGKA26H; Lot # 992201, Exp. Date 01/08/2021 (64 kits)",
      "center_classification_date": "20200529",
      "distribution_pattern": "US Nationwide distribution including in the state of Pennsylvania.",
      "state": "PA",
      "product_description": "Sterile Custom Packs to  be used in surgical procedures.",
      "report_date": "20200610",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "American Contract Systems",
      "recall_number": "Z-2177-2020",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "85502",
      "termination_date": "20201125",
      "recall_initiation_date": "20200413",
      "postal_code": "16063-2838",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}