{
  "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": "1 lot/60 units",
      "code_info": "Product code 900-2270,1  lot  112125073",
      "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": "LAPAROSCOPY CHOLE SYSTEM PACK      MIAMI METRO  CON\tTENTS:\t  (12)  TOWELS CLOTH HUCK BLUE LIF  (1)   MAYO STAND COVER REINFORCED LIF (1)    TABLE COVER REINFORCED 50\" X 90\" LIF (1)   SUTURE BAG FLORAL LIF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF (1)   BULB SYRINGE 60cc LIF  (1)   BLADE SURGICAL #10 STAINLESS STEEL  (2)   SHEET%  60\" X 77\"  DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (1)    BLADE SURGICAL #15 CARBON STEEL (1)    TUBE SUCTION CONNECT Y.\" X 12'  LIF (1)    BAG GLASSINE PLAIN  (1)    CAUTERY TIP POLISHER LIF  (1) \tDRAPE LAP. ABDOMINAL WITH POUCH 102\" X 122\" X 78\" LIF (1)\tPK. STRIP STERI CLOSURE W'  X 4\" LIF  (1)    SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1)    CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1)    COUNTER NEEDLE BLADE 30c MAG/FOAM  (1)   TIME OUT BEACON NON WOVEN  LIF  (1)    GOWN XL SMS IMPERVIOUS REINFORCED LIF  (1)    GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1)   TOWEL ABSORBENT 15\" X 20\" LIF  (1)    BLADE SURGICAL #11 CARBON STEEL  (1)   TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1)   YANKAUER OPEN TIP CLEAR WITHOUT C IV   LIF    ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1)   ACTIFOG WITH/FOAM  PAD SOLUTION LIF    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-2447-2014",
      "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"
    }
  ]
}