{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "29 lots; 2144 units (multiple units per lot)",
      "code_info": "Product code 900-2003, 29 lots:  112030702  112041277  112062472  112093923  112103923  112114386  112114472  112125311  113015438  113025954  113026205  113036457  113047011  113047156  113057447  113057696  113057814  113068159  113078779  113089205  113099569  131110221  131110405  131110582  140211725  140211874  140312378  140312461  140412832",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "GENERAL PACK -   CONTENTS: (4) ABSORBENT TOWEL 15\" x 20\" LIF  (1) MAYO STAND COVER REINFORCED LIF  ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF  (2) UTILITY BOWL 16 oz. LIF  (1) GLASINE BAG PLAIN  ( 1) SUTURE BAG FLORAL  (4) DRAPE UTILITY WITH TAPE LIF  ( 1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) SURGICAL BLADE# 10 STAINLESS STEEL  ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF  ( 1) LAPAROTOMY T DRAPE STD SMS  (2) DRAPE SHEET 41\" X 58\" SMS LIF  (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF  (1 0) GAUZE 4\"X 4\" X 4 PLY  ( 1) CAUTERY TIP POLISHER LIF  (5) LAP SPONGES PRE-WASH XRD LIF  ( 1) CAUTERY PENCIL ROCKER SWITCH LIF  (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY XRD LIF  ( 1) TUBE SUCTION CONNECT. 3/16\" X 12' LIF  ( 1) SURGICAL BLADE# 15 CARBON STEEL  ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL    Product Usage:  EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2428-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}