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.

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

Code information: Lot numbers VTCV0414, VTCW0469, VTCW0470, VTCY0566, VTCZ0640, VTCZ0648, and VTCZ0649.

Distribution pattern: 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.