{
  "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-1240-2013",
      "product_description": "Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator  Product Code: PEB623    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": "59089 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:  2000101  2044006  2044008  2044009  2065654  2117203  2117204  2120950  2138835  2152580  2152582  2156663  2165851  2165852  2170920  2170926  2295309  2304187  2304192  2304193  2304194  2304196  2304197  2304198  2305241  2305243  2313279  2324539  2327973  2327974  2336959  2341411  2341412  2341414  2341415  2341416  2341420"
    }
  ]
}