{
  "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": "22 lots; 968 units (multiple units per lot)",
      "code_info": "Product code 900-1496, 22 lots:  112041078  112051677  112062422  112114953  113015550  113025817  113026047  113036320  113036750  113057690  113067952  113088734  113099274  113109735  131110178  131210749  140111077  140211644  140311921  140412602  140513092  140513391",
      "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": "D & C LAPAROSCOPY PACK -   (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT  (1) MAYO STAND COVER REINFORCED UF  (4) DRAPE UTILITY UF  (1) TRAY MAYO SMALL LIF  (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL  (1) SUTURE BAG FLORAL LIF  (1) TUBE SUCTION CONNECT X\" X 12' LIF  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (2) LEGGINGS WITH 7\" CUFF 30\" X 42\" LIF  (1) UTILITY BOWL 32oz. UF  (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX  (2) DRESSING NON ADH TELFA 4 X 3 ST. UF  (1) JELLY LUBRICATING FIVE GRAM  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) *Pk. STERI STRIP LAP SET LATEX  (1) COVER CAMERA W/ELAST UF  (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF  (4) TOWELS ABSORBENT 15\" X 20\" UF  (1) DRAPE LAP. PERINEAL WITH POUCH 102\" X 97\" SOFT SMS UF  (2) LIGHT SHIELD  (1) DRESSING TEGADERM 4\" X 4 %\" LIF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD UF  (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP  (1) SCALPEL WEIGHTED SAFETY #11  (1) BAG ZIP LOCK  (1) Pk. STRIP STERI CLOSURE W' X 4\" LIF  (1) TIME OUT BEACON NON WOVEN ST. UF  (1) BANDAGE GAUZE STRETCH 4\"  (1) NEEDLE ULTRA VERES 120MM UF  (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF  (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER 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-2397-2014",
      "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"
    }
  ]
}