{
  "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": "Mason",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86707",
      "recalling_firm": "Haag-Streit USA Inc",
      "address_1": "3535 Kings Mills Rd",
      "address_2": "N/A",
      "postal_code": "45040-2303",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the state of OK.",
      "recall_number": "Z-0697-2021",
      "product_description": "Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515)  in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view",
      "product_quantity": "3 units US",
      "reason_for_recall": "Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by  pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye",
      "recall_initiation_date": "20201120",
      "center_classification_date": "20201223",
      "report_date": "20201230",
      "code_info": "Floor stands FS 2-11, FS 2-15 with the software REF 615 588 in versions 2.0 to 3.3.     FS 2-11          Ref. # 615H511  Serial Numbers:From 1001;  FS 2-15          Ref. #615H515   Serial Numbers From 1001;  HS Hi-R NEO 900  Ref. # 657    Serial Numbers 820 from 101;  HS Hi-R NEO 900A  Ref # 657 821 Serial Numbers from 101      Unique Device Identifier (UDI)   HS Hi-R NEO 900                +EMWM657 820 0/$+serial no.   HS Hi-R NEO 900A             +EMWM657 821 0/$+serial no.   FS 2 11                                +EMWM 615H5110/$+serial no.   FS 2-15                                 +EMWM 615H515 0/$+serial no."
    }
  ]
}