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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74295

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 31, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hologic, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2239-2016
Recall number
Z-2239-2016
Initiated
May 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
Hologic, Inc
Quantity
16,870

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cracks ATEC Canister Lids.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cracks ATEC Canister Lids.

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.