{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Bloomington",
      "address_1": "4801 W. 81st St.",
      "reason_for_recall": "Potential that product has not reached complete sterilization,",
      "address_2": "",
      "product_quantity": "51,152 units total",
      "code_info": "Tray Number (Lot Number):      a. Tray Number: LSRBASICPACD (1610281, 1611301, 1701041, 1701301, 1702111, 1702201, 1703171, 1703232, 1704101, 1705052, 1705061, 1705092, 1705252, 1706141, 1707101, 1708041, 1708291, 1710132);      b. Tray Number: LSRCFHANGD (1611091, 1701052, 1702232, 1703141, 1705082, 1705101, 1707071, 1708301);      c. Tray Number: LSRCFBVIIIPKE (1709071/2);      d.  Tray Number: LSRCFBVIIIPKD (1612021, 1701251, 1703142, 1704111, 1705241, 1707171, 1708071);      e. Tray Number: LSRGABRSB (1701112, 1703101, 1704271, 1706082, 1708112);      f. Tray Numbers: LSRCARDCATHF (1706271, 1707131, 1707241, 1708141, 1708311, 1710011, 1710031), LSRCFHCATHE (1610291, 1611281, 1612282, 1701231, 1702041, 1702071, 1703071, 1703202, 1703271, 1703301, 1704141, 1704192,1704282, 1705091, 1705182, 1705232, 1705312, 1706121);      g. Tray Number: LSRCFHCARC (1611111, 1701101, 1702272, 1705012, 1706201, 1707221);      h. Tray Number: LSRCFHCARD (1709061, 1710241);      i. Tray Number: LSRCFHCATHD (1610312, 1611181, 1612301, 1701231, 1702032, 1702041, 1702081, 1702231, 1703162, 1704121, 1704261, 1705051, 1705161, 1705241, 1706082, 1706211, 1707101, 1707261, 1708151, 1709011, 1710052, 1710261);      j. Tray Number: LSRCFHCYTURC (1611181, 1702062, 1702141, 1703151, 1704262, 1705171, 1706261, 1707171, 1708142, 1709052, 1710271);      k. Tray Number: LSRCFHDCGYNC (1611032, 1701281, 1703221, 1705012, 1706081, 1707221, 1709292);      l. Tray Number: LSRLMDCA (1611071, 1702081, 1704192, 1707241, 1710091);      m. Tray Number: LSRCFENTB (1611031, 1612162, 1701231, 1703081, 1704291, 1706121, 1707201);      n. Tray Number: LSRCFENTC (1708231);      o. Tray Numbers: LSRENDOSCOPG (1611041, 1701041, 1702151), LSRENDOSCOPH (1703301, 1705051/2, 1706061, 1707032, 1708011, 1709061, 1710271);      p. Tray Number: LSRLMENDOVB (1611021, 1703062, 1703292, 1704271, 1705091, 1708251);      q. Tray Number: LSRMISCA (1702181);      r. Tray Number: LSRHPGYND (1611071, 1612211, 1702092, 1704061, 1705102, 1706161, 1707201, 1709191);       s. Tray Number: LSRKNEEARTHF (1611291, 1612241, 1702141, 1703081, 1704182, 1705171, 1707062, 1708182);      t. Tray Number: LSROCCULARC (1611171, 1703152, 1705052, 1708042);      u. Tray Number: LSROPHTHALD (1611021, 1701301, 1703292, 1707141);       v. Tray Number: LSRPICCLINEG (1612212, 1702061, 1703151, 1704291, 1706131, 1707181, 1708311);      w. Tray Number: LSRSHOULDERD (1611302, 1701131, 1702092, 1703082, 1704061, 1706031, 1708182);      x. Tray Number: LSRSINGLEBA (1610261, 1611151, 1611221, 1612091, 1612232, 1701101, 1701172, 1701312, 1702022, 1702092, 1702111, 1702181, 1702231, 1703181, 1704011, 1704112, 1704191, 1704282, 1705011, 1705081, 1705181/2,1705221, 1705311,1706121, 1706141, 1706201, 1707071, 1707121, 1707171, 1707221, 1707271, 1708071, 1708101, 1708112, 1708141, 1708241, 1708312, 1709071, 1709201, 1710021, 1710122, 1710241);      y. Tray Number: LSRCFHPACRE (1612191, 1702061, 1704251, 1704261, 1706151, 1707142, 1708181, 1710102);      z. Tray Number: LSRVAGDELIVC (1612021, 1701251, 1703161, 1704242, 1706061, 1707032, 1708021, 1708172, 1709201);      aa. Tray Number: LSRDECYSTA (1611091, 1611141, 1612211, 1702062, 1702141, 1703012, 1704182, 1705032, 1705171, 1709061, 1710181);      bb. Tray Number: LSRDEMINB (1611111, 1612051, 1701311, 1703301, 1706011, 1706052, 1707071, 1707261, 1708171, 1709291)",
      "center_classification_date": "20190227",
      "distribution_pattern": "US Distribution is to Florida.",
      "state": "MN",
      "product_description": "Bag size #4 Custom Convenience Kits     Usage:  Surgical convenience kits    labeled as the following:    a. Tray Name: PACK BASIC SET UP LH - 2035102,  Tray Number: LSRBASICPACD;      b. Tray Name: PACK ANGIOGRAM CFH - 2071297,  Tray Number: LSRCFHANGD;      c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE;      d.  Tray Name: PACK BASIC VIII CFH -2072667,  Tray Number: LSRCFBVIIIPKD;      e. Tray Name: PACK BREAST GARRAMONE, Tray Number: LSRGABRSB;      f. Tray Name: PACK CARDIAC CATH LH - 2073653, Tray Numbers: LSRCARDCATHF, LSRCFHCATHE;      g. Tray Name: PACK CAROTID CFH - 2022261, Tray Number: LSRCFHCARC;      h. Tray Name: PACK CAROTID CFH - 2070082, Tray Number: LSRCFHCARD;      i. Tray Name: PACK CATH PACK CFH - 2065429, Tray Number: LSRCFHCATHD;      j. Tray Name: PACK CYSTO-TUR CFH - 2066423,  Tray Number: LSRCFHCYTURC;      k. Tray Name: PACK D-C GYN CFH - 2023208, Tray Number: LSRCFHDCGYNC;      l. Tray Name: PACK D-C LH - 2067690, Tray Number: LSRLMDCA;      m. Tray Name: PACK EENT CFH - 2023005, Tray Number: LSRCFENTB;      n. Tray Name: PACK EENT CFH - 2073904, Tray Number: LSRCFENTC;      o. Tray Name: PACK ENDOSCOPIC LH - 2073429, Tray Numbers: LSRENDOSCOPG, LSRENDOSCOPH;      p. Tray Name: PACK ENDOVENOUS LH - 2072299, Tray Number: LSRLMENDOVB;      q. Tray Name: PACK GENERIC A - 2018972, Tray Number: LSRMISCA;      r. Tray Name: PACK HP GYN LAPAROSCOPY LH -2067955, Tray Number: LSRHPGYND;       s. Tray Name: PACK KNEE ARTHROSCOPY SMHS - 2065237, Tray Number: LSRKNEEARTHF;      t. Tray Name: PACK OCCULAR DRAPE LH - 2034766, Tray Number: LSROCCULARC;      u. Tray Name: PACK OPHTHALMOLOGY LH - 2034932, Tray Number: LSROPHTHALD;       v. Tray Name: PACK PICC LINE LH - 2008070, Tray Number: LSRPICCLINEG;      w. Tray Name: PACK SHOULDER SMHS - 2065241, Tray Number: LSRSHOULDERD;      x. Tray Name: PACK SINGLE BASIN LH - 2064837, Tray Number: LSRSINGLEBA;      y. Tray Name: PACK STOCK PACEMAKER CFH - 2069578, Tray Number: LSRCFHPACRE;      z. Tray Name: PACK VAGINAL DELIVERY SMHS - 2068301, Tray Number: LSRVAGDELIVC;      aa. Tray Name: PACK CYSTO DECATUR - 2047265, Tray Number: LSRDECYSTA;      bb. Tray Name: PACK MINOR DECATUR - 2071628, Tray Number: LSRDEMINB",
      "report_date": "20190306",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "American Contract Systems, Inc.",
      "recall_number": "Z-0964-2019",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "81710",
      "termination_date": "20210210",
      "more_code_info": "",
      "recall_initiation_date": "20181121",
      "postal_code": "55437",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}