{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220251",
      "product_res_number": "Z-2526-2026",
      "event_date_initiated": "2026-04-21",
      "event_date_posted": "2026-06-23",
      "recall_status": "Open, Classified",
      "res_event_number": "98942",
      "product_code": "DXE",
      "k_numbers": [
        "K011783"
      ],
      "product_description": "Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310",
      "code_info": "REF/UDI-DI/Lot(Expiration):\n147305/04042301061829/1049868(10/14/2028);\n147310/04042301033567/1049960(10/20/28)",
      "firm_fei_number": "3013666218",
      "recalling_firm": "PFM MEDICAL INC.",
      "address_1": "1916 Palomar Oaks Way",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92008-5523",
      "additional_info_contact": "760-758-8749 Ext. 222",
      "reason_for_recall": "A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 4/21/2026, recall notices were emailed to customers who were asked to do the following:\n1. Inform all customers (hospitals and clinics) and device users (physicians) who have received or used affected batches. This notification should also be shared with any organizations where the potentially affected devices have been transferred.\n2. Return unused devices from the affected batches to PFM Medical, Inc.\n3. Complete the enclosed Recall Response Form and email back to recall@pfmmedicalusa.com",
      "product_quantity": "32",
      "distribution_pattern": "US Nationwide distribution in the states of NY, MD.",
      "openfda": {
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        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}