{
  "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": "Le Noirmont",
      "state": "N/A",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86419",
      "recalling_firm": "Bien-Air Surgery Sa",
      "address_1": "rue de l' ouest 2b",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of CA, MI and MN.",
      "recall_number": "Z-0178-2021",
      "product_description": "Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.",
      "product_quantity": "Total US = 1120 foot pedals",
      "reason_for_recall": "The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.",
      "recall_initiation_date": "20200911",
      "center_classification_date": "20201021",
      "report_date": "20201028",
      "code_info": "Model 1600686 / Catalog number 1600686-001  Serial Numbers:  18D0006  18D0007  18D0008  18D0009  18D0010  18D0013  18D0014  18D0015  18D0016  18D0017  18D0018  18D0019  18D0020  18D0021  18D0022  18D0023  18D0024  18D0025  18D0026  18D0027  18D0028  18D0029  18D0030  16A0005  16A0009  16A0010  16A0011  16A0014  17D0011  17G0006"
    }
  ]
}