Exact FDA event identifier

Event 98172

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

Open FDA event record

Event summary

Timeline bucket: December 15, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
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

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Z-1314-2026

Recall number: Z-1314-2026
Initiated: December 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Hologic, Inc
Quantity: 681,870 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulates

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Presence of particulates in affected devices that can be deposited into breast tissue during use.

Code information

Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.

Distribution pattern

US Nationwide distribution.