{
  "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": "19 lots; 351 units (multiple units per lot)",
      "code_info": "Product code 900-1967, 19  lots:  111123453  112030696  112041219  112041457  112051908  112062470  112083417  112125164  113015692  113025952  113026107  113026233  113047010  113057694  113078292  140211807  140312103  140412626  140412893",
      "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 PACK -   ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F  ( 1) NEEDLE ULTRA VERES 120MM LIF  ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF  ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF  (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III  (1) MAYO STAND COVER REINFORCED LIF  (5) SPONGE LAP PREWASH 18\" X 18\" XRD LIF  ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF  ( 1) BOWL UTILITY 16oz. LIF  (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF  (1) DRAPE LASER CAMERA W/EL 6\" X 96\" LIF  (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY XRD LIF  (4) DRAPE UTILITY WITH TAPE LIF  (4) TOWELS ABSORBENT 15\" X 20\" LIF  (1) DRAPE ENDOSCOPY 100\" X 123%\" X 77\" WITH TROUGHS L/F  (2) SHEET DRAPE 42\" X 57\" SMS LIF  (1) BLADE SURGICAL #11 STAINLESS STEEL  ( 1) TIME OUT BEACON NON WOVEN ST L/F  (6) GAUZE SPONGE 2\" X 2\" 4PL Y LIF  ( 1) BLADE SURG. #15 CARBON STEEL  ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF  (1) TABLE COVER REINFORCED 50\" X 90\" L/F    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-2424-2014",
      "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"
    }
  ]
}