CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

EnCor Breast Biopsy Probes, packaged individually recalled

Bard Peripheral Vascular is recalling EnCor Breast Biopsy Probes, packaged individually in sterile, 5 pouches/carton, single, distributed nationwide in the US. The recall was initiated on 2 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number VTCW0467.

Quantity recalled239 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2212-2019
FDA event ID: 83303
Recalling firm: Bard Peripheral Vascular, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 2 May 2019
FDA classified: 7 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

2 May 2019	Recall initiated by company
7 Aug 2019	Classified by FDA	+97 days
14 Aug 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Is EnCor Breast Biopsy Probes, packaged individually in sterile, 5 pouches/carton, single recalled?

Yes. Bard Peripheral Vascular recalled EnCor Breast Biopsy Probes, packaged individually in sterile, 5 pouches/carton, single on 2 May 2019. The recall is Class II and its status is Terminated. Recall number Z-2212-2019.

Why was it recalled?

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

Which lots are affected?

Lot number VTCW0467.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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