Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number:…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 850 W Rio Salado Pkwy · Tempe, AZ · 85281-3802
Is this the product you have?
- EnCor EnCompass Breast Biopsy and Tissue
- Removal System Console (model numberENCPCONSOLE)
- and Driver (model numberENCPDRIVER) with software
- Lot codes and dates
- Software Versions 1.1.1.10207 and 1.2.0.12133
- UDI-DI00801741235221 and 00801741234248
- Serial Numbers
99 of 99 codes
VTLNPX06VTLNPX0FVTLNPX0DVTLNPX08VTLNPX0KVTLNPX0AVTLNPX0CVTLNPX0LVTLNPX0JVTLNPX04VTLNPX0HVTLNPX02VTLPPX1GVTLPPX1DVTLPPX1CVTLPPX1MVTLPPX2HVTLPPX2IVTLPPX2FVTLQPX15VTLQPX1QVTLQPX1GVTLQPX14VTLQPX0TVTLQPX1YVTLQPX1MVTLQPX2GVTLQPX1OVTLQPX1KVTLQPX19VTLQPX2EVTLQPX1WVTLQPX10VTLQPX1ZVTLQPX24VTLQPX21VTLQPX0XVTLQPX1EVTLQPX0UVTLQPX26VTLQPX2FVTLQPX25VTLQPX0ZVTLQPX18VTLQPX28VTLQPX20VTLQPX27VTLQPX11VTLQPX2BVTLQPX1FVTLQPX2HVTLQPX41VTLQPX3TVTLQPX43VTLRPX0RVTKYPX09VTKYPX44VTKYPX46VTKYPX47VTKYPX48
- Amount recalled
- 99
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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