Use caution Medical device recall · FDA · Published August 20, 2026

Bard Breast Biopsy System May Cause Procedure Interruptions - Recall 2026

Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console and Driver with specific software versions and serial numbers due to potential calibration errors that could interrupt procedures or require repeat biopsies.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3275-2026Medical device Bard Peripheral Vascular ›

Use caution until it’s fixed

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.

✎ GovInfoNow plain-language explainer

Bard Peripheral Vascular Inc is recalling EnCor EnCompass Breast Biopsy and Tissue Removal System Console and Driver units with specific software versions and serial numbers. These devices may experience calibration errors that could interrupt the biopsy procedure or require additional tissue sampling. Read more at govinfonow.com/recall/1449317-bard-peripheral-vascular-inc-recalls-encor-encompass-breast-biopsy-and.

Source Summary by GovInfoNow · govinfonow.com/recall/1449317-bard-peripheral-vascular-inc-recalls-encor-encompass-breast-biopsy-and · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3275-2026

Cite this page

“Bard Breast Biopsy System May Cause Procedure Interruptions - Recall 2026.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449317-bard-peripheral-vascular-inc-recalls-encor-encompass-breast-biopsy-and. Based on FDA recall #Z-3275-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3275-2026%22&limit=1).

The Food and Drug Administration announced on Aug. 20, 2026, that Bard Peripheral Vascular Inc is recalling its EnCor EnCompass Breast Biopsy and Tissue Removal System Console and Driver due to potential calibration errors. These defects may interrupt biopsy procedures or necessitate additional tissue sampling.

How to tell if you have it

Brand: Bard Peripheral Vascular
Product: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER)
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, VLRPX0R, 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, VLRPX0X, VLRPX0Z, VTKYPX07, VTKYPX06, VTKYPX04, VTLNPX4B, VTLNPX42, VTLNPX4F, VTLPPX3D, VTLQPX0M, VTKYPX51
Units affected: 99

The hazard

According to the FDA, the system may experience probe calibration or handheld driver failure (code HH01-00020009) and pressure sensor errors (code E01-0054000E). These errors prompt users to restart and re-calibrate, which may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.

Context

GovInfoNow's records show Bard Peripheral Vascular Inc has issued 40 other recalls since Sept. 22, 2017. Other recent recalls include a Dec. 12, 2025, recall for Broviac Cutdown Trays due to sterile barrier compromise risk and an Aug. 21, 2025, recall for Venclose digiRF Generators that may cause false failures. Other recent recalls of similar products include a May 21, 2026, Bard Soft Tissue Biopsy Trays Recall for lidocaine ampoule manufacturing deficiency and an April 24, 2026, HydroMARK Breast Biopsy Marker Recall for incorrect labeling risk.

How to tell if you have this one

Check for the model numbers ENCPCONSOLE and ENCPDRIVER with software versions 1.1.1.10207 or 1.2.0.12133. The recall includes specific serial numbers listed in the UDI-DI and serial number ranges provided in the record.

Brand
Bard Peripheral Vascular
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Numbers
Verify if your device has serial numbers from the list provided in the recall record, such as VTLNPX06, VTLNPX0F, etc.
Restart and Recalibrate
If errors occur, restart the system and recalibrate as prompted by the error codes HH01-00020009 or E01-0054000E.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 20 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin.

Recall timeline

FDA published this recall 48 days after the firm started it.

Aug 20, 2026Firm started the recall
Sep 25, 2026FDA classified it Class II
Oct 7, 2026Published in FDA’s Enforcement Report
Oct 13, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/1449317-bard-peripheral-vascular-inc-recalls-encor-encompass-breast-biopsy-and">Bard Breast Biopsy System May Cause Procedure Interruptions - Recall 2026 (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3275-2026 (August 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3275-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.