{
  "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": "Terminated",
      "city": "Pacheco",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87426",
      "recalling_firm": "Biocare Medical, LLC",
      "address_1": "60 Berry Dr",
      "address_2": "",
      "postal_code": "94553-5601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY    OUS: Germany, Netherlands",
      "recall_number": "Z-1333-2021",
      "product_description": "BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument,  Ref: \"\tModel Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1",
      "product_quantity": "72 units",
      "reason_for_recall": "Their is a potential that the  automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on  random locations.",
      "recall_initiation_date": "20210225",
      "center_classification_date": "20210401",
      "termination_date": "20230131",
      "report_date": "20210407",
      "code_info": "Affected US Serial Numbers:  BCIP01-0021, BCIP01-0033, BCIP01-0090, BCIP01-0106,  BCIP01-0112, BCIP01-0148, BCIP01-0151, BCIP01-0187,  BCIP01-0189, BCIP01-0198, BCIP01-0201, BCIP01-0216,  BCIP01-0221, BCIP01-0249, BCIP01-0262, BCIP01-0265, BCIP01-0266, BCIP01-0268, BCIP01-0279, BCIP01-0285, BCIP01-0307, BCIP01-0314, BCIP01-0319, BCIP01-0328,  BCIP01-0341, BCIP01-0346, BCIP01-0354, BCIP01-0386,  BCIP01-0387, BCIP01-0388, BCIP01-0390, BCIP01-0395,  BCIP01-0396, BCIP01-0413, BCIP01-0426, BCIP01-0430,  BCIP01-0431, BCIP01-0432, BCIP01-0434, BCIP01-0443,  BCIP01-0450, BCIP01-0463, BCIP01-0464, BCIP01-0467,  BCIP01-0482, BCIP01-0484, BCIP01-0487, BCIP01-0491,  BCIP01-0492, BCIP01-0495, BCIP01-0500, BCIP01-0502,  BCIP01-0508, BCIP01-0517, BCIP01-0526, BCIP01-0534,  BCIP01-0543, BCIP01-0545, BCIP01-0546, BCIP01-0550,  BCIP01-0553, BCIP01-0555, BCIP01-0560, BCIP01-0562,  BCIP01-0570, BCIP01-0571, BCIP01-0572, BCIP01-0573    Affected OUS serial numbers:  BCIP01-0454, BCIP01-0515, BCIP01-0538, BCIP01-0556",
      "more_code_info": ""
    }
  ]
}