{
  "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": "3 lots/280 units,(multiple units per lot)",
      "code_info": "Product code 900-2259A, 3  lots  140312025  140412651  140612902",
      "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 COLORECTAL SURGICAL \tPACK    CONTENTS:\t  (1) \tSOLUTION SURGICAL DURAPREP 26ml LIF   (4) \tDRAPE UTILITY WITH TAPE LIF  (3)    TOWELS ABSORBENT 15\" X 20\" LIF   (2) \tLEGGINS W/7'' CUFF 30\" X 42\" LIF  (1) \tBLADE SURGICAL# 15 STAINLESS  STEEL  (1) \tBLADE SURGICAL# 11 STAINLESS STEEL  (1)   GOWN IMPERV. EXTRA REINF. XLG  AAMI Ill LIF  (1) \tIRRIGATION SUCTION TROMPET DUAL SPIKE LIF   (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (2)    UTILITY  BOWL 16oz. LIF  (2)    PK. STERI STRIP CLOSURE%'' X 4\" L/F  (1)  ACTIFOG WITH FOAM PAD SOLUTION LIF   (1)   TABLE  COVER REINFORCED 50\" X 90\" LIF   (1)   MAYO STAND COVER REINFORCED LIF   (1)    NEEDLE ULTRA VERES  120MM LIF  (1)  STAPLE ARTICULATING ECHEL 60MM LIF   (1)  RELOAD WHITE 60MM  ECHELON L/F  (2) \tCANNULA 5MM XCEL SLEEVES  LIF  (1)    TROCAR 5MM BLADELE W/STAB SLEEVE UF   (1)   TROCAR 12MM BLADELE  W/STAB  SLEEVE LIF   (10)  LAP SPONGES PREWASH 18\" X 18\" XRD LIF  (1)    TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF   (2) \tLITE GLOVE  (1) \tPENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF   (1) \tELECTRODE DUAL DEPRES  (1) \tLAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES   (1)    COUNTER NDLE/BLADE 20C FOAM/MAG LIF  (1) \tSKIN MARKER  INK W/8 LABEL/TIME OUT/RULER LIF  (1) \tBAG SUTURE  FLORAL  (1)    GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF   (1) \tPOLISHER CAUTERY TIP LIF  (1) \tBAG GLASSINE  (1) \tRELOAD BLUE 60MM LIF  (1)   TIME OUT BEACON NON WOVEN 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-2445-2014",
      "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"
    }
  ]
}