{
  "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": "3 lots; 36 units (multiple lots per unit)",
      "code_info": "Product code 900-1835,  3 lots:  113109763  131210771  140412619",
      "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": "HIP ORTHOPEDIA PACK -   (1) BLADE SURGICAL #15 STAINLES /STEEL  (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) MAYO STAND COVER REINFORCED LIF  (4) DRAPE UTILITY WIT APE LIF  (4) TOWEL ABSORBENT 15\" X 20\" LIF  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (2) DRAPE SHEET 41\" X 58\" SMS LIF  (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF  (10) GAUZE 4\" X 4\" 4PLY  (2) UTILITY BOWL 16oz LIF  (1) CAUTERY TIP POLISHER LIF  (1) SUTURE BAG FLORAL  (1) BLADE SURGICAL#10 STAILESS STEEL  (1) SURGICAL DURAPREP SOLUTION 26m! LIF  (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL  (10)GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (5) LAP SPONGE PRE WASH 18\" X 18\" XRD LIF  (1) CAUTERY PENCIL ROCKER SWITCH LIF  (1) TUBE SUCTION CONNECT. 3/16\" X 12' LIF  (1) DRAPE INCISE ANTIMICROBIAL 23\" X 33\"  (2) SHEET DRAPE 70\" X 100\" LIF  (1) DRAPE TOP WITH ADHESIVE 108\" X 50\" STD SMS LIF  (1) SHEET SPLIT WITH ADHESIVE 108\" X 77\" STD SMS L/F    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-2415-2014",
      "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"
    }
  ]
}