{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Alpharetta",
      "address_1": "11810 Wills Rd Ste 100",
      "reason_for_recall": "The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.",
      "address_2": "ATTN: Theron Gober",
      "product_quantity": "253 units",
      "code_info": "Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS,  F1C0219FUSE1CS,  F1C0220FUSE1CS,  F1C0221FUSE1CS,  F1C0222FUSE1CS,  F1C0223FUSE1CS,  F1C0224FUSE1CS,  F1C0225FUSE1CS,  F1C0228FUSE1CS, F1C0229FUSE1CS,  F1C0230FUSE1CS, F1C0231FUSE1CS,  F1C0232FUSE1CS, F1C0233FUSE1CS,  F1C0235FUSE1CS,  F1C0236FUSE1CS,  F1C0237FUSE1CS,  F1C0238FUSE1CS,  F1C0239FUSE1CS,  F1C0241FUSE1CS,  F1C0243FUSE1CS,  F1C0245FUSE1CS,  F1C0246FUSE1CS,  F1C0247FUSE1CS,  F1C0248FUSE1CS,  F1C0249FUSE1CS,  F1C0250FUSE1CS,  F1C0251FUSE1CS, F1C0252FUSE1CS,  F1C0253FUSE1CS,  F1C0254FUSE1CS,  F1C0255FUSE1CS,  F1C0256FUSE1CS,  F1C0257FUSE1CS,  F1C0258FUSE1CS,  F1C0259FUSE1CS, F1C0261FUSE1CS,  F1C0262FUSE1CS, F1C0263FUSE1CS,  F1C0264FUSE1CS,  F1C0266FUSE1CS,  F1C0267FUSE1CS,  F1C0268FUSE1CS,  F1C0269FUSE1CS,  F1C0270FUSE1CS,  F1C0271FUSE1CS,  F1C0272FUSE1CS,  F1C0273FUSE1CS,  F1C0274FUSE1CS,  F1C0276FUSE1CS,  F1C0277FUSE1CS,  F1C0278FUSE1CS,  F1C0279FUSE1CS,  F1C0280FUSE1CS,  F1C0281FUSE1CS, F1C0282FUSE1CS, F1C0284FUSE1CS,   F1C0285FUSE1CS, F1C0287FUSE1CS, F1C0288FUSE1CS, F1C0289FUSE1CS, F1C0290FUSE1CS, F1C0291FUSE1CS, F1C0292FUSE1CS, F1C0293FUSE1CS, F1C0294FUSE1CS, F1C0296FUSE1CS, F1C0297FUSE1CS, F1C0298FUSE1CS, F1C0299FUSE1CS, F1C0300FUSE1CS, F1C0301FUSE1CS, F1C0305FUSE1CS ; Item number: FSC-330-C6333, Model number: C38s-150, Serial numbers: 0600200, 0600201, 0600202, 0600203, 0600204, 0600205 and 0600206; Item number: FSC-3300-ST, Model number: F1C,  Serial numbers: F1C0214FUSE1C-150F1C0241FUSEC1, F1C0244FUSE1C-A, F1C0244FUSEC1, F1C0255FUSE1C-A, F1C0259FUSE1C, F1C0271FUSE1C, F1C0283FUSE1C, F1C0312FUSE1C, F1C0313FUSE1C, F1C0322FUSE1C, F1C0334FUSE1C, F1C0356FUSE1C, F1C0382FUSE1C, F1C0388FUSE1C, F1C0425FUSE1C, F1C0433FUSE1C, F1C0437FUSE1C, F1C0447FUSE1C,  F1C0449FUSE1C, F1C0458FUSE1C, F1C0461FUSE1C, F1C0475FUSE1C, F1C0479FUSE1C, F1C0484FUSE1C, F1C0488FUSE1C, F1C0489FUSE1C, F1C0516FUSE1C, F1C0526FUSE1C, F1C0530FUSE1C, F1C0531FUSE1C, F1C0536FUSE1C, F1C0537FUSE1C, F1C0540FUSE1C, F1C0542FUSE1C, F1C0543FUSE1C, F1C0544FUSE1C, F1C0545FUSE1C, F1C0546FUSE1C,  F1C0547FUSE1C, F1C0549FUSE1C, F1C0584FUSE1C, F1C0586FUSE1C,  F1C0603FUSE1C, F1C0640FUSE1C, F1C0660FUSE1C, F1C0668FUSE1C,  F1C0691FUSE1C, F1C0692FUSE1C, F1C0693FUSE1C, F1C0694FUSE1C,  F1C0709FUSE1C, F1C0714FUSE1C, F1C0736FUSE1C, F1C0739FUSE1C,  F1C0742FUSE1C, F1C0745FUSE1C, F1C0749FUSE1C, F1C0758FUSE1C,  F1C0763FUSE1C, F1C0765FUSE1C, F1C0767FUSE1C, F1C0776FUSE1C, F1C0778FUSE1C, F1C0779FUSE1C, F1C0786FUSE1C, F1C0790FUSE1CL, F1C0791FUSE1CL, F1C0794FUSE1C, F1C0796FUSE1C, F1C0799FUSE1C,   F1C0800FUSE1CL, F1C0802FUSE1C, F1C0806FUSE1C, F1C0811FUSE1C,  F1C0812FUSE1C, F1C0814FUSE1C, F1C0817FUSE1C, F1C0818FUSE1C,  F1C0825FUSE1C, F1C0827FUSE1C, F1C0828FUSE1C,  F1C0829FUSE1C,  F1C0831FUSE1C, F1C0833FUSE1C, F1C0834FUSE1C, F1C0835FUSE1C,  F1C0837FUSE1C, F1C0838FUSE1C, F1C0841FUSE1C, F1C0849FUSE1C,  F1C0852FUSE1C, F1C0857FUSE1C, F1C0858FUSE1C, F1C0859FUSE1C,  F1C0860FUSE1C, F1C0862FUSE1C, F1C0863FUSE1C, F1C0864FUSE1C,  F1C0866FUSE1C, F1C0867FUSE1C, F1C0868FUSE1C, F1C0870FUSE1C,  F1C0871FUSE1C, F1C0872FUSE1C, F1C0873FUSE1C, F1C0874FUSE1C,  F1C0875FUSE1C, F1C0876FUSE1C, F1C0878FUSE1C, F1C0879FUSE1C,  F1C0880FUSE1C, F1C0883FUSE1C, F1C0884FUSE1C, F1C0885FUSE1C,  F1C0893FUSE1C, F1C0894FUSE1C, F1C0895FUSE1C, F1C0898FUSE1C,  F1C0900FUSE1C, F1C0902FUSE1C, F1C0905FUSE1C, F1C0906FUSE1C,  F1C0907FUSE1C, F1C0908FUSE1C, F1C0910FUSE1C F1C0921FUSE1C; Item number: FSC330-A6334, Model number: F1C-MC90, Serial numbers: 0700200, 0700204, 0700205, 0700207, 0700209, 0700210, 0700212, 0700215 and 0700217; Item number: FDC-3300-133, Model number: Fuse Colo 133, Serial numbers: F1C0201FUSE1C-133, F1C0202FUSE1C-133, F1C0203FUSE1C-133,  F1C0204FUSE-133, F1C0205FUSE1C-133, F1C0206FUSE1C-133, F1C0207FUSE1C-133,  F1C0208FUSE1C-133, F1C0209FUSE1C-133, F1C0210FUSE1C-133,  F1C0211FUSE1C-133, F1C0216FUSE1C-133, F1C0217FUSE1C-133,  F1C0218FUSE1C-133, F1C0219FUSE1C-133, F1C0221FUSE1C-133,  F1C0222FUSE1C-133, F1C0223FUSE1C-133, F1C0224FUSE1C-133,  F1C0225FUSE1C-133, F1C0226FUSE1C-133, F1C0227FUSE1C-133, F1C0228FUSE1C-133, F1C0229FUSE1C-133, F1C0230FUSE1C-133,  F1C0235FUSE1C-133 and Item number: FSC-3300-150, Model number: Fuse Colo 150, Serial numbers: F1C0202FUSE1C-150, F1C0203FUSE1C-150, F1C0204FUSE1C-150, F1C0205FUSE1C-150, F1C0206FUSE1C-150, F1C0207FUSE1C-150, F1C0208FUSE1C-150, F1C0209FUSE1C-150, F1C0210FUSE1C-150, F1C0211FUSE1C-150, F1C0212FUSE1C-150, F1C0214FUSE1C-150.",
      "center_classification_date": "20160127",
      "distribution_pattern": "Worldwide Distribution.  US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.",
      "state": "GA",
      "product_description": "Fuse 1C Colonoscope",
      "report_date": "20160203",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "EndoChoice, Inc.",
      "recall_number": "Z-0694-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73067",
      "termination_date": "20160324",
      "recall_initiation_date": "20151218",
      "postal_code": "30009-2081",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}