# Class II recall Z-3275-2026: Bard Peripheral Vascular Inc

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3275-2026 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software |
| 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. |
| Quantity | 99 |
| 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. |
| Recall initiated | 2026-08-20 |
| Reported | 2026-10-07 |
| Firm location | Tempe, AZ, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3275-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.