{
  "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": [
    {
      "status": "Terminated",
      "city": "Keene",
      "state": "NH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64705",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "10 Bowman Dr",
      "address_2": "N/A",
      "postal_code": "03431-5043",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).",
      "recall_number": "Z-1239-2013",
      "product_description": "Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters  (with ultrasound)  Product Code: PE623    Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.",
      "product_quantity": "22380 units",
      "reason_for_recall": "Unable to pass catheter through outer sheath during embryo transfer",
      "recall_initiation_date": "20130328",
      "center_classification_date": "20130503",
      "termination_date": "20210519",
      "report_date": "20130515",
      "code_info": "Lot Codes:  2000099  2044001  2044005  2117201  2117202  2120953  2138832  2138833  2161554  2304181  2304182  2304199  2305239  2305240  2308138  2313278  2332537  2336956  2336957  2341409  2341410  2344790"
    }
  ]
}