{
  "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",
      "code_info": "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 PACK   code 900-2259A, contains:  (1) SOLUTION SURGICAL DURAPREP 26ml LIF  (4) DRAPE UTILITY WITH TAPE LIF  (3) TOWELS ABSORBENT 15\" X 20\" LIF  (2) LEGGINS W/7'' CUFF 30\" X 42\" LIF  (1) BLADE SURGICAL# 15 STAINLESS STEEL  (1) BLADE SURGICAL# 11 STAINLESS STEEL  (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF  (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF  (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y 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) CANNULA 5MM XCEL SLEEVES LIF  (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF  (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF  (1 0) LAP SPONGES PREWASH 18\" X 18\" XRD LIF  (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF  (2) LITE GLOVE  (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF  (1) ELECTRODE DUAL DEPRES  (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES  (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF  (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF  (1) BAG SUTURE FLORAL  (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF  (1) POLISHER CAUTERY TIP LIF  (1) BAG GLASSINE  (1) RELOAD 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.  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-2533-2014",
      "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"
    }
  ]
}