{
  "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": "5 lots/214 units, (multiple units per lot)",
      "code_info": "Product code 900-2204, 5 lots  112050723  112062283  112083422  112093930  112125070",
      "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  CONTENTS:  ( I )    BULB SYRINGE 60cc LIF  ( I 0) GAUZE SPONGE 4\" X 4\" 1 6PLY XRD LIF  ( I )    MAYO STAND COYER REINFORCED LIF  ( I )   TABLE COVER REINFORCED 50\" X 90\" LIF  (3)   GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4)   TOWEL ABSORBENT I 5\" X 20\" LIF  ( I )    DRAPE VIDEO CAMERA I 3cm X 244cm LIF   (3)    LITE G LOVE LIF  ( I )    DRAPE LAP ABDOM. WI POUCH 102\" X 122\" X 78\"   ( I )    BLADE SURG ICA L # II  STAIN LESS STEEL  ( I)   SYRINGE I Occ W ITHOUT  NEEDLE LUER LOCK LIF (4)    DRAPE UTILITY WITH TAPE LIF  ( I )    SUTURE BAG FLORAL  (I)    NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1'   ( I )    CABLE LAP. IOFR 4MM  MALE MONOP. LIF\t  (2)  DRESSING NON ADH TELfoA 4 X 3  ( I )   SPECIMEN CONTAINER 4oz WITH LID & LABEL   (2)   SH EET 'll.o    60\" X 77\" DRAPE R EI NFORCED LIF  ( I )  TUBING INSUFFLAT  SET WIO RING ADAPTOR LIF   ( I )   CI-I LORAPREP 26ML APPLICATOR TEAL LIF  ( I )   WRAPPER 24\" X 24\"  (2)   DENTURE CUP 8oz WILID    ADHERED OUTSIDE OF THE PACK INTO A POUCH:   ( I )  NEEDLE ULTRA VERES 1 20MM LIF  ( I )  TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT)  ( I )  TROCA R ENDO.XCEL DILATING TIP LIF (K5LT)  ( I )   CANNU LA 5MM XCEL SLEEVES LIF    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-2440-2014",
      "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"
    }
  ]
}