{
  "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": "25 lots; 2382 units (multiple units per lot)",
      "code_info": "Product code 900-1780, 25  lots:  112010094  112020415  112041205  112051885  112072786  112083376  112083453  112104301  112114612  112125037  113015436  113036758  113057839  113068042  113078279  113088764  113099281  113109757  131110203  131110602  140111178  140211654  140312436  140513114  140513454",
      "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": "OPHTALMIC PACK -      (1) GOWN LGE SMS NON REINF TIWRAP   (1) IODINE POVIDONE 1oz.  (2) TOWEL ABSORBENT 15\" x 20\" UF   (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF  (6) COTION TIP APPLICATOR 6\" WOOD   (1) TABLE COVER REINFORCED 50\" X 90\" UF  (1) PAD EYE 2 1/8 X 2 5/8   (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8  (1) SHIELD EYE UNIVERSAL   (1)  Pr. GLOVES SURG.# 7% LATEX  (10) SPONGE EYE SPEAR MICRO   (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF  (10) GAUZE SPONGES 4\" X 4\" 12PL Y   (1) Pr. GLOVES SURG. 8 POWDER LATEX  (1) MAYO STAND COVER REINFORCED UF   (1) BLADE 15D WITH HANDLE (STABKNIFE)  (1) EYE DRAPE   (1) GOWN LARGE STANDARD SMS  (1) TRAY 3/COMPART   (1) BAG ZIP LOCK  (1) ANGLED FULL HANDLE   (1 ) Pr. GLOVES SURGICAL# 6% LATEX    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-2412-2014",
      "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"
    }
  ]
}