Lower riskMedical device recall · FDA · Published December 15, 2025
Hologic Brevera Breast Biopsy Needle Recall: Particulates Risk
Hologic recalls Brever: Particulates in disposable 9 gauge biopsy needles may deposit in breast tissue during use. Affected units include all lots within expiry date.
“Hologic Brevera Breast Biopsy Needle Recall: Particulates Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50453-hologic-brevera-breast-biopsy-needle-recall-particulates-risk. Based on FDA recall #Z-1314-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2026%22&limit=1).
Hologic, Inc. recalled the Brevera Breast Biopsy System Disposable 9 Gauge Needle on Dec. 15, 2025, due to particulates that may deposit into breast tissue during use, the FDA said. The voluntary Class II recall affects 681,870 units distributed nationwide.
How to tell if you have it
Brand: Hologic
Product: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Model No: BREVDISP09
UDI: 1540045512863
Lot codes: All Lots within expiry
The hazard
The affected devices contain particulates that can be deposited into breast tissue during use. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Hologic, Inc. has issued 30 other recalls since June 27, 2017. Recent Hologic recalls include the SELENIA Dimensions Mammography Systems Recall on April 8, 2026, and the Genius Review Station Display Recall on March 23, 2026. Other recent recalls of similar products include Medline Recalls Olympus Biopsy Kits (Feb. 16, 2026), AVID Medical Halyard Kits Recall (April 30, 2026), and Medline Namic Preceptor Manifold Recall (March 24, 2026).
How to tell if you have this one
Check for the model number BREVDISP09 on the needle packaging. The recall includes all lots within the expiry date.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Needle Packaging
Look for the model number BREVDISP09 on the needle packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1314-2026 (December 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1314-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.