{
  "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": "22 lots/784 units, (multiple units per lot)",
      "code_info": "Product code 900-2123, 22 lots  112041293  112041377  112051685  112083162  112093925  112104110  112114603  113015564  113026273  113036460  113036691  113078467  113088788  113109787  131110236  131210645  140111094  140211658  140312117  140412557  140513124  140613657",
      "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": "KNEE ARTHROSCOPY PACK    CONTENTS:    (1)    TOWEL ABSORBENT 15\" X 20\" L/F (10) GAUZE SPONGE  4\" X 4\" 16PLY  (1) \tSAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) \tNEEDLE HYPODERMIC 18G X 1Y:z  (1) \tU-DRAPE 60\" X 70\" WITH TAPE SPLIT (1) \tSKIN MARKER INK W/8 LABEL  (2)    TUBE SUCTION CONNECT. W X 12' LIF (1)    CAST PADDING SOFT ROLL 6 X 4yds L/F  (2) \tBANDAGE ELASTIC 6\" X 5yds L/F (4)    STRIP TAPE 24\" X 4\" LIF  (1) \tPk. STERI STRIP CLOSURE Y:z\"  X 4\" LIF (1)    SHEET ARTHROSCOPY \"T\" STD SMS  W/POUCH  L/F\t  (5) \t LAP SPONGE PREWASH 18\" X 18\" XRD LIF (1) \tNEEDLE SPINAL  ANESTHESIA 18G X 3% LIF (1)    SYRINGE 10cc W/0 NDL L/LOCK LIF  (1) \tDRAPE VIDEO CAMERA 13cm X 244cm LIF (1)    GOWN IMPERV. XTRA REINF. LGE TIWRAP (1)    MAYO STAND COVER REINFORCED LIF  (2) \tNEEDLE HYPODERMIC 25 X 1Y:z LIF  (1)    TIME OUT BEACON NON WOVEN ST. LIF  (1)    STOCKINETTE IMPERV. 14\" X 48\" LIF (1)    TABLE COVER REINF. 50\" X 90\" LIF (1)    SCALPEL WEIGHTED SAFETY #11  (1)   SAFETY GLIDE NEEDLE 21G X 1%  (1)    GOWN SURG. REINF. XL EXTRA LONG LEVEL IV      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-2435-2014",
      "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"
    }
  ]
}