FDA Medical Device Recalls (openFDA)
Hologic, Inc: ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
- Recall number
- Z-2239-2016
- Recalling firm
- Hologic, Inc
- Product
- ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
- Status
- Terminated
- Initiated
- 2016-05-31
- Posted
- 2016-07-19
- Terminated
- 2017-05-24
- Reason
- Cracks ATEC Canister Lids.
- Root cause
- Process control
- Action
- Customers were notified of the recall via certified letter beginning on May 31, 2016. The letter requests that customers immediately inventory your supplies of the Recalled product in all appropriate areas and cease use of all affected stock. In addition, they are asked to complete the enclosed Recall Response Card indicating whether you have any of the Recalled product on hand, as well as the quantity of product that you have in stock.
- Quantity
- 16,870
- Distribution
- 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.
- Lot, serial or model codes
- Lot Number: 20150013 and 20150014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDQ
- Firm FEI
- 1000120743
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28