# FDA recall Z-2213-2019

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2019-05-02.

## Product

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide distribution, including Puerto Rico.  There was government and foreign distribution and no military distribution.    Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe,  Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.

## Key facts

- **Recall number:** Z-2213-2019
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-02
- **Report date:** 2019-08-14
- **Termination date:** 2022-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2019

## Citation

> AI Analytics. FDA recall Z-2213-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2213-2019. Source: US FDA. Licensed CC0.

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