{
  "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": "Redwood City",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82462",
      "recalling_firm": "PROCEPT BIOROBOTICS CORPORATION",
      "address_1": "900 Island Dr Ste 101",
      "address_2": "N/A",
      "postal_code": "94065-5176",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia.",
      "recall_number": "Z-1110-2019",
      "product_description": "AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System.  320301 distributed outside the U.S.    Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).",
      "product_quantity": "214",
      "reason_for_recall": "Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.",
      "recall_initiation_date": "20190306",
      "center_classification_date": "20190408",
      "termination_date": "20201113",
      "report_date": "20190417",
      "code_info": "Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244.    Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234"
    }
  ]
}