{
  "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": "47 lots; 5560 units (multiple units per lot)",
      "code_info": "Product code 900-660,  47 lots:  110061532  110071635  110071853  110102449  110112671  110122899  111010148  111020375  111030650  111040914  111051212  111061560  111071832  111082224  111092400  111102775  111112949  111123281  112010195  112020516  112030737  112041345  112052004  112062504  112083440  112093591  112093732  112114595  112125107  113015698  113025966  113036597  113036730  113057500  113057875  113068179  113088883  113099295  113109867  131110270  131110412  131110589  131210972  140111453  140211677  140211945  140513352",
      "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": "CESAREAN PACK-  -   (3) ABSORBENT TOWELS 15\" x 20\" LIF  (1) PLASTIC BOWL WITH LID 80oz.  (1 0) LAP SPONGES PRE-WASH 18\" x 18\" XRD  (2) PAD OBSTETRICAL X-LARGE ST.  (1) MAYO STAND COVER REINFORCED LIF  (1) DRAPE SHEET 41\" x 58\" SMS LIF  (2) TUBE SUCTION CONNECT. Y..\" X 12' LIF  (1) EAR ULCER SYRINGE 2oz. LIF  (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F  (1) UMBILICAL CORD CLAMP  (1) SURGICAL BLADE #20 CARBON STEEL  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF  (1) DRESSING ISLAND 4\" X 1 0\"  (1) C-SECTION DRAPE WITH POUCH 102\" X 121\" X 78\"  (1) BABY BLANKET PRINTED  (1) GOWN IMPERVIOUS REINFORCED LARGE SMS  (1) BAG SUTURE FLORAL    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-2343-2014",
      "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"
    }
  ]
}