{"recall":{"id":"fda-device-99590","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model ","firm":"Bard Peripheral Vascular Inc","date":"2026-08-20","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software","code":"Software Versions 1.1.1.10207 and 1.2.0.12133. UDI-DI: 00801741235221 and 00801741234248. Serial 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","quantity":"99","number":"Z-3275-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"99","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99590","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c64255f7257c1806","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99590","record":[{"status":"Ongoing","city":"Tempe","state":"AZ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99590","recalling_firm":"Bard Peripheral Vascular Inc","address_1":"850 W Rio Salado Pkwy","address_2":"","postal_code":"85281-3802","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-3275-2026","product_description":"EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software","product_quantity":"99","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.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"Software Versions 1.1.1.10207 and 1.2.0.12133. UDI-DI: 00801741235221 and 00801741234248.  Serial 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","more_code_info":""}]}}