{
  "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 different 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": "21 lots; 690 units (multiple units per lot)",
      "code_info": "Product code 900-1176, 21 lots:  112051673  112051735  112062336  112083210  112093723  112114597  112114925  113025928  113036747  113078239  113078679  113089017  113099562  140111074  140211461  140211717  140312052  140312421  140412913  140513071  140513476",
      "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": "LAP AROSCOPY PACK -   (10) GAUZE SPONGE 4\" X 4\" 16 PLY XRD LIF  (1) MAYO STAND COVER REINFORCED L/F  (4) ADHESIVE BANDAGE%\" X 3\" ST. LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) GOWN IMPERVIOUS REINFORCED LARGE SMS  (2) TOWEL ABSORBENT 15\" X 20\" LIF  (1) DRAPE LASER CAMERA W/EL 6\" X 96\" LIF  (2) LITE GLOVE LIF  (1) TUBE SUCTION CONNECTING W X 12' LIF  (1) DRAPE LAP WITH POUCH 102\" X 121 \" X 78\" STD SMS  (1) BLADE SURGICAL #11 STAINLESS STEEL  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (4) DRAPE UTILITY WITH TAPE L/F  (1) BAG SUTURE FLORAL  (1) TUR Y SET, 2 LEAD L/F  (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF  (1) GOWN STANDARD LARGE SMS VELCRO NECK  (1) TUBE SUCTION CONNECT 3/16\" X 12' LIF  (1) Pk. STERI STRIP LAP. LATEX  (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (1) CAUTERY PENCIL ROCKER SWITCH LIF    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-2377-2014",
      "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"
    }
  ]
}