{
  "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": "12 lots; 450 units (multiple units per lot)",
      "code_info": "Product code 900-1202, 12 lots:  112051738  113078681  113099269  113109712  131110160  131210629  140111078  140211462  140211633  140311918  140412586  140513335",
      "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": "LAMINECTOMY PACK -  ( I) RING BASIN LIF   (2) TABLE COVER REINFORCED 50\" X 90\" LIF  ( I) SKIN MARKER INK W/8 LABEL   ( I) CAUTERY TIP POLISHER LIF  ( I) TUBE SUCTION CONNECT. W' X 12' LIF   (6) DRAPE UTILITY W/TAPE LIF  (I 0) GAUZE SPONGE 4\" X 4\" 16PL Y LIF   (2) UTILITY BOWL 16oz. LIF  ( IO) LAP SPONGE PRE-WASH XRD LIF   (2) SPECIMEN CONTAINER 4oz W/LID & LABEL  (2) MAYO STAND COVER REINFORCED LIF   ( I) GOWN SURG. REINF. XL TOWEL WRAP  (6) ABSORBENT TOWEL I5\" X 20\" LIF   ( I) DRAPE LAP 102\" X 121\" X 78\" W/POUCI-1 SMS LIF  ( I) SURGICAL DURAPREP SOLUTION 26ML LIF   (6) DRAPE SHEET 41\" X 69\" MEDIUM LIF  (2) LEGGING W/7'' CUFF 30\" X 42\" LIF   (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR  ( I) CAUTERY PENCIL PUSH BOTTOM LIF   ( I) BAG SUTURE FLORAL LIF  ( I) PVP SCRUB 8\" STICK SPONGE   ( I) MAYO TRAY LARGE LIF  (I 0) GAUZE SPONGE 4\" X 4\" 16PL Y XRD LIF   ( I) SURGICAL BLADE# I 0 CARBON STEEL  (2) BULB SYRINGE 60cc CLEAR LIF   ( I) SURGICAL BLADE# I I CARBON STEEL  ( I) SURGICAL BLADE # 15 CARBON STEEL   ( I) GOWN FABRIC REINFORCED SONTARA XL LIF  ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF  ( I) PVP PAINT 8\" STICK SPONGE  ( I) SURGICAL STRIP W' X 6\" COTTON   (2) LITE GLOVES LIF    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-2379-2014",
      "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"
    }
  ]
}