CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report

Atec Canister recalled by Hologic

Hologic is recalling Atec Canister, distributed in 44 states. The recall was initiated on 31 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 20150013 and 20150014

Quantity recalled16,870

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-2239-2016
FDA event ID: 74295
Recalling firm: Hologic, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2016
FDA classified: 19 Jul 2016
Reported: 27 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 May 2016	Recall initiated by company
19 Jul 2016	Classified by FDA	+49 days
27 Jul 2016	Published in enforcement report	+8 days

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

Reason for recall

Cracks ATEC Canister Lids.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Is Atec Canister recalled?

Yes. Hologic recalled Atec Canister on 31 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2239-2016.

Why was it recalled?

Cracks ATEC Canister Lids.

Which lots are affected?

Lot Number: 20150013 and 20150014

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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