{ "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": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221919", "product_res_number": "Z-3275-2026", "event_date_initiated": "2026-08-20", "event_date_posted": "2026-09-25", "recall_status": "Open, Classified", "res_event_number": "99590", "product_code": "KNW", "k_numbers": [ "K252681" ], "product_description": "EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software", "code_info": "Software Versions 1.1.1.10207 and 1.2.0.12133.\nUDI-DI: 00801741235221 and 00801741234248.\n\nSerial Numbers: VTLNPX06, VTLNPX0F, VTLNPX0D, VTLNPX08, VTLNPX0K, VTLNPX0A, VTLNPX0C, VTLNPX0L, VTLNPX0J, VTLNPX04, VTLNPX0H, VTLNPX02, VTLPPX1G, VTLPPX1D, VTLPPX1C, VTLPPX1M, VTLPPX2H, VTLPPX2I, VTLPPX2F, VTLQPX15, VTLQPX1Q, VTLQPX1G, VTLQPX14, VTLQPX0T, VTLQPX1Y, VTLQPX1M, VTLQPX2G, VTLQPX1O, VTLQPX1K, VTLQPX19, VTLQPX2E, VTLQPX1W, VTLQPX10, VTLQPX1Z, VTLQPX24, VTLQPX21, VTLQPX0X, VTLQPX1E, VTLQPX0U, VTLQPX26, VTLQPX2F, VTLQPX25, VTLQPX0Z, VTLQPX18, VTLQPX28, VTLQPX20, VTLQPX27, VTLQPX11, VTLQPX2B, VTLQPX1F, VTLQPX2H, VTLQPX41, VTLQPX3T, VTLQPX43, VTLRPX0R, VTKYPX09, VTKYPX44, VTKYPX46, VTKYPX47, VTKYPX48, VTKYPX49, VTKZPX14, VTKZPX15, VTKZPX20, VTKZPX17, VTLNPX4I, VTLNPX49, VTLNPX4G, VTLNPX4N, VTLNPX4E, VTLNPX4L, VTLNPX44, VTLNPX46, VTLNPX4C, VTLPPX27, VTLPPX28, VTLPPX29, VTLPPX1Z, VTLPPX37, VTLPPX3B, VTLPPX34, VTLPPX38, VTLPPX36, VTLQPX0Q, VTLQPX0B, VTLQPX0E, VTLQPX0P, VTLQPX0F, VTLRPX0X, VTLRPX0Z, VTKYPX07, VTKYPX06, VTKYPX04, VTLNPX4B, VTLNPX42, VTLNPX4F, VTLPPX3D, VTLQPX0M, VTKYPX51", "firm_fei_number": "2020394", "recalling_firm": "Bard Peripheral Vascular Inc", "address_1": "850 W Rio Salado Pkwy", "city": "Tempe", "state": "AZ", "postal_code": "85281-3802", "additional_info_contact": "844-823-5433", "reason_for_recall": "Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.", "root_cause_description": "Software design", "action": "On 8/20/2026, correction notices were mailed to customer who were asked to do the following:\n\n1.If calibration cannot be completed, clinicians should first follow the troubleshooting instructions provided on the screen and in the Instructions for Use (IFU). If the issue persists, the probe should be replaced and the process repeated. If unsuccessful, an alternative biopsy driver or system should be used, as clinically appropriate.\n2. If a pressure sensor error is observed, clinicians should follow the troubleshooting instructions provided on the screen and in the Instructions for Use (IFU). If the error occurs and the system cannot be returned to normal operations, discontinue use of the affected system and complete or reschedule using alternative equipment, as clinically appropriate. No additional follow-up is recommended for patients whose procedures were completed without complication.\n3. If affected devices function as intended or if the error codes can be cleared, facilities can continue to use them prior to software update.\n4. Post the correction notice on or near affected devices until the software has been updated.\n5. Ensure devices are available for the update.\n6. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Share this notification with all product users within your facility network to ensure they are also aware of this product correction. If the affected products have been distributed further, please ensure that these entities are contacted and informed of the correction.\n7. Complete and return the response form via email to BDRC33@bd.com\n\nFirm has developed a software solution to address these issues. A firm representative will contact your facility to arrange the update.\n\nIf you require assistance, contact the firm via email: productcomplaints@bd.com, or phone: 1-844-823-5433", "product_quantity": "99", "distribution_pattern": "US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC, ID, MI, KY, CT, IL, VA, MA, WI, NY, IN, TN, OH, UT.", "openfda": { "k_number": [ "K980004", "K922939", "K080171", "K980211", "K211933", "K974312", "K002546", "K123259", "K013108", "K960065", "K980676", "K981320", "K233031", "K244018", "K090611", "K010037", "K033616", "K020848", "K930201", "K885169", "K962977", "K252183", "K033427", "K953880", "K243095", "K781038", "K052435", "K930241", "K020987", "K963390", "K252795", "K912892", "K904658", "K210946", "K190378", "K913098", "K200278", "K851836", "K180233", "K851798", "K180807", "K053151", "K011206", "K130282", "K050795", "K243945", "K990515", "K171531", "K112468", "K170539", "K003370", "K222462", "K111100", "K022169", "K011104", 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"Gastroenterology, Urology", "regulation_number": "876.1075", "device_class": "2" } } ] }