{
  "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": "4 lots, 180 units ( multiple units per lot)",
      "code_info": "Code 900-2903, 4 lots  113026303  113057705  113068034  113088858",
      "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": "ORTHOPEDIC IMPLANT \t  PACK CUSTOMED USA, CODE 900-2903  CONTENTS:  (1)   CAUTERY TIP  POLISHER UF \t  (1)   SKIN MARKER W/RULER  (1)   BAG SUTURE FLORAL \t  (1)   U - DRAPE 60\" X 70\" WITAPE SPLIT 6\" X 21\"  (1)  TUBE SUCTION CONNECT W' X 12' UF \t  (2)   PAD ABDOMINAL 8\" X 7.5\"  (1)   BAG GLASSINE\t  (1)  YANKAUER SUCTION TUBE W/0 VENT LIF   (2)   LITE GLOVE UF \t  (1)   SOLUTION SURGICAL DURAPREP 26ML LIF  (2)  TABLE COVER REINFORCED 50\" X 90\" LIF   (1)   BLADE SURGICAL# 10 STAINLESS STEEL  (1)   MAYO STAND COVER REINFORCED LIF \t  (1)   SHEET SPLIT W/ADHES 108\" X 77\" STD SMS L/F   (5)  TOWELS ABSORBENT 15\" X 20\" UF \t  (1)   STOKINETIE IMPERVIOUS 14\" X 48\" LIF  (2)   DRAPE SHEET 70\" X 100\" LIF   (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX   (5)   LAP SPONGE PREWASH 18\" X 18\" XRD LIF \t  (1) *GLOVE # 8 SURGEON NEUTRALON LATEX   (1)   SKIN STAPLE 35 WIDE UF \t  (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX  (1)  TRAY MAYO LGE \t  (1)   GOWN SURG REINFORCED XL TOWEUWRAP  (1)   DRAPE TOP W/ADHES 108\" X 50\" STD SMS UF   (2)   GOWN XL SMS IMPERVIOUS REINFORCED UF   (1)   BULB SYRINGE 60cc CLEAR\t  (1)   CAUTERY PENCYL ROCKER SWITCH UF  (1)   UTILITY BOWL 16oz LIF \t  (1)   BLADE SURGICAL#  20 STAINLESS STEEL   (1)   UTILITY BOWL QUART 32oz LIF \t  (4)   DRAPE UTILITY WITAPE UF  (1)   DRAPE INCISION 23\" X 17\" UF    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-2509-2014",
      "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"
    }
  ]
}