{
  "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": "Bochum",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88213",
      "recalling_firm": "INNOVATIVE TOMOGRAPHY PRODUCT GMBH",
      "address_1": "Universitatsstr. 136",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of CA.",
      "recall_number": "Z-2164-2021",
      "product_description": "Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:     Article no. BIM 18/10, Length 100 mm, Diameter\t18 G (1.25 mm);  Article no. BIM 18/15, Length 150 mm, Diameter\t18 G (1.25 mm);  Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm);   Article no. BIM 16/10, Length 100 mm, Diameter\t16 G (1.6 mm);  Article no. BIM 16/15, Length 150 mm, Diameter\t16 G (1.6 mm);  Article no. BIM 16/20, Length 200 mm, Diameter\t16 G (1.6 mm);  Article no. BIM 14/10, Length 100 mm, Diameter\t14 G (2.1 mm);  Article no. BIM 14/15, Length 150 mm, Diameter\t14 G (2.1 mm);  Article no. BIM 14/20, Length 200 mm, Diameter\t14 G (2.1 mm)    *NOT DISTRIBUTED WITHIN THE US",
      "product_quantity": "N/A",
      "reason_for_recall": "Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized",
      "recall_initiation_date": "20210421",
      "center_classification_date": "20210729",
      "report_date": "20210804",
      "code_info": "Affected Lot Numbers:    BIM 18/10: LOT: 4918;   BIM 18/15: LOT: 4017, 4918, 4719;   BIM 18/20: LOT: 4017, 4918;   BIM 16/10: LOT: 4918, 1119, 1219;   BIM 16/15: LOT: 4918, 1119;   BIM 16/20: LOT: 4918, 1119;   BIM 14/10: LOT: 4918, 3019;   BIM 14/15: LOT: 4918;   BIM 14/20: LOT: 4918"
    }
  ]
}