{
  "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": "Brescia",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88437",
      "recalling_firm": "Copan Italia",
      "address_1": "Via Francesco Perotti 10",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide distribution, including Puerto Rico.",
      "recall_number": "Z-2440-2021",
      "product_description": "COPAN FLOQSwabs, STERILE.EO,  for drawing clinical samples.  CE0123, for the following reference numbers  REF:501CS01,  Minitip, sterile Single Wrapped, Molded bp 80mm;   REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs;  REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20;  REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm;   REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm;   REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm;    REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm  REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm;    REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed;   REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm;   REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm;  REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm;   REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm;  REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm;   REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube   REF: 534CS01, Flexible Nylon, Sterile Single Wrapped;   REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm;   REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm;   REF: 553C, Flexible sterile in dry tube, molded bp 100 mm;  REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm;   REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper;    5U048N01.BIO,   REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch;   REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only;   REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only",
      "product_quantity": "3,029,400 units",
      "reason_for_recall": "A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.",
      "recall_initiation_date": "20210709",
      "center_classification_date": "20210909",
      "termination_date": "20240125",
      "report_date": "20210915",
      "code_info": "Mode Number: Lot number:  501CS01: 1816581 and 2027890; 501CS01.Q100: PJ10453, PJ10636 and PJ10667; 501CS01.Q20: J10407; 502CS01: 1816964, 2027239, 2027877; 503CS01: 1807589, 1809095, 1814761, 1814762, 1814763, 1816968, 1821362, 2025887; 503CS01.BD: 2031801; 503CS01.BX: 50U004DS and 1818685; 50U009DS02: 1825274; 518CS01: 2008058 and 2027915; 518CS01.BD: 2008058; 519C: 1816921; 519C.BX: 1811060 and 1816921;  519CS01.BD: 2027871; 525CS01: 2009380; 528C: 1808601, 534CS01, 1707256; 551C: 1813221; 552C: 1819144; 552C.BX: 1819144; 553C: 1810293, 1816440, 1817638, 2004854: 553C.LC: 1811976, 1814054, 1814717, 1817637, 1820999; 5U002S: 1812705; 5U048N01.BIO: 1810727 and 1818912; 5U055S02.HG: 1814413; 5U056S.IUO: 1816448; 5U057S.IUO: 1816451",
      "more_code_info": ""
    }
  ]
}