Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EnCor Breast Biopsy Probes Recalled by Bard Peripheral Vascular Inc Due to There has been an increase in complaints related...

Date: May 2, 2019
Company: Bard Peripheral Vascular Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.

Affected Products

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Quantity: 12,833 units

Why Was This Recalled?

There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report