Class II recall Z-3275-2026: Bard Peripheral Vascular Inc
Class II recall Z-3275-2026: Bard Peripheral Vascular Inc (Arizona): Bard Peripheral Vascular Inc. Dated 29 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 5 related AZ FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (6 AZ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-3275-2026: Bard Peripheral Vascular Inc and 6 Arizona peers
- Arizona FDAPulse records like this one: 6
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Arizona peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.
What is the FDAPulse record for Class II recall Z-3275-2026: Bard Peripheral Vascular Inc in Arizona?
Class II device recall Z-3275-2026 by Bard Peripheral Vascular Inc: Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld drive
How does Class II recall Z-3275-2026: Bard Peripheral Vascular Inc compare to other Arizona FDAPulse records?
It is 29 days old, still within a typical 45-day follow-up window.
Class II recall Z-3275-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3275-2026 | AZ | 2026-10-07 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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