{
  "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": "Minnetonka",
      "address_1": "10700 Bren Rd W",
      "reason_for_recall": "AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles.  The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.",
      "address_2": "",
      "product_quantity": "184 (110 US, 74 OUS)",
      "code_info": "Lot Number  861912018  861914016  862631001  862639018  863952005  863960024  863962007  865584018  865585013  865593007  865869024  865882006  867705012  868952010  868961016  868962022  868964021  869672008  869673021  869683007  870935011  870935017  870936016  870936023  870937001  870938022  870940022  871927006  871927014  871930002  873243013  873243015  873247017  873253025  873944005  873945017  873946003  873949005  873950009  873951024  873952024  875055017  875060017  875060024  876016019  876025002  877253005  877259010  878159022  878160012  878162016  878164009  878165016  878168017  878168021  878975023  880215004  880217014  881145009  881146023  881149014  881150018  881152025  882234015  882236002  882239002  882240012  882241016  882243015  882245014  883312010  883313020  883315019  883319013  883319014  883319015  884416007  884416024  884420017  884422015  884422018  884423025  885166007  885166024  885170004  885170022  886256007  886256021  886257022  886260022  886260024  886260025  886261024  886262010  886263002  886263017  886264010  886264024  886848011  886848012  886849016  886855001  886855019  886858004  886858011  886858014  887908021  887909002  887909003  887909008  887910017  887912005  887912006  887915009  887917021  888755008  888755012  888758013  888762005  888762015  889654010  889656003  889656005  889656006  889656023  889657013  889657014  890573015  890573017  890576003  890577015  890578013  890579011  890579016  890580017  890581001  890581002  890581003  890581004  890581005  890581006  890581007  890581018  890581024  890582011  890582012  890582013  891506011  891506012  891507012  891507014  891507021  891508002  891508019  891508020  891508021  891509005  891509006  891510011  891511001  891511002  891513002  891513003  891513024  891515003  891516015  892497013  892497014  892498002  892501001  892501002  892501003  892501004  892501012  892501016  892501017  892501018  892501019  892501020  892501021  892501022  892501023  892501024  892501025",
      "center_classification_date": "20141113",
      "distribution_pattern": "Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and COLOMBIA.",
      "state": "MN",
      "product_description": "AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850.    Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.",
      "report_date": "20141119",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "American Medical Systems, Inc.",
      "recall_number": "Z-0209-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69536",
      "termination_date": "20150928",
      "more_code_info": "",
      "recall_initiation_date": "20141010",
      "postal_code": "55343-9679",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}