Hologic, Inc: Medical Device Recall in 2016 - (Recall #: Z-2239-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

Product Classification:

Class II

Date Initiated: May 31, 2016
Date Posted: July 27, 2016
Recall Number: Z-2239-2016
Event ID: 74295
Reason for Recall:

Cracks ATEC Canister Lids.

Status: Terminated
Product Quantity: 16,870
Code Information:

Lot Number: 20150013 and 20150014

Distribution Pattern:

Worldwide distribution. US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: United Arab Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Qatar, Singapore, Thailand, Taiwan, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated