{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "187965",
      "product_res_number": "Z-2229-2021",
      "event_date_initiated": "2021-01-12",
      "event_date_created": "2021-08-06",
      "recall_status": "Completed",
      "res_event_number": "88136",
      "product_code": "OCZ",
      "k_numbers": [
        "K974300"
      ],
      "product_description": "Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 \n\nIntended use: single use accessory devices used through the working channel of a GI endoscope",
      "code_info": "Lot Code: 020377208",
      "firm_fei_number": "1222168",
      "recalling_firm": "Shent USA, Inc.",
      "address_1": "8 Kane Industrial Dr",
      "city": "Hudson",
      "state": "MA",
      "postal_code": "01749-2906",
      "additional_info_contact": "Florencia Trevino\n978-567-9033",
      "reason_for_recall": "Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and  Devices labeled as catalog #7226,  (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230\ncm).",
      "root_cause_description": "Packaging process control",
      "action": "Telemed issued Urgent Medical Device Recall letter on 1/12/21. Letter states reason for recall, health risk and action to take:\nPlease respond to this recall notification (email response is acceptable) to let us know whether or not you have any of the recalled product in your inventory. If you are in possession of any recalled devices, please provide the quantity, catalog number and lot number. All affected devices must be returned to TeleMed; upon receiving your response to this notification, TeleMed Customer Service will provide you with an RGA number for product return. If you have any questions regarding this medical device recall, please contact: prakash@telemedsystems.com. 508-723-6609;\nCustomerservice@telemedsystems.com  978-567-9033",
      "product_quantity": "47 units (20 US; 27 OUS)",
      "distribution_pattern": "US Nationwide Distribution - CA, CO, MI\nForeign: Australia",
      "openfda": {
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        "device_name": "Endoscopic Grasping/Cutting Instrument, Non-Powered",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}