{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86562",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "address_2": "",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Argentina  Ecuador  Lebanon  Saudi Arabia  Australia  Estonia  Malaysia  Serbia  Austria  Finland  Malta  Singapore  Bahrain  France  Mexico  Slovenia  Belarus  Germany  Netherlands  South Africa  Belgium  Great Britain  New Zealand  South Korea  Brazil  Greece  Norway  Spain  Canada  Guatemala  Panama  Sweden  Chile  Hong Kong  Poland  Switzerland  China  India  Portugal  Taiwan  Colombia  Iran  Puerto Rico  Thailand  Costa Rica  Ireland  Qatar  Turkey  Croatia  Israel  Romania  United Arab Emirates  Czech Republic  Italy  Russian Fed.  Dominican Republic",
      "recall_number": "Z-0427-2021",
      "product_description": "AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis",
      "product_quantity": "24,064",
      "reason_for_recall": "The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.",
      "recall_initiation_date": "20200924",
      "center_classification_date": "20201106",
      "report_date": "20201118",
      "code_info": "UPNs  72404310    72404280  72404281  72404282  72404282-10  72404283  72404283-12  72404284  72404284-14  72404285  72404286  72404287  72404288  72404289    72404300  72404301  72404302  72404302-10  72404303  72404303-12  72404305  72404306  72404307  72404308    72404209    72404260  72404261  72404262  72404263  72404264  72404265  72404266  72404267  72404268  72404269    72404230  72404231  72404232  72404232-10  72404233  72404233-12  72404234  72404234-14  72404235  72404236  72404237  72404238  72404239    72404250  72404251  72404252  72404252-10  72404253  72404253-12  72404255  72404256  72404257  72404258    To determine if a UPN/serial number is impacted, visit: www.bostonscientific.com/lookup",
      "more_code_info": ""
    }
  ]
}