Hologic Brevera Breast Biopsy Needle Recall: Particulates Risk

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Contact the company & request your remedy

Recalling firmHologic, Inc250 Campus Dr, N/A · Marlborough, MA 01752-3020

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Hologic is recalling disposable 9-gauge breast biopsy needles that may contain particulates which could deposit in breast tissue during use. This poses a potential risk of tissue contamination.

Why it’s dangerous

Particulates in the needle could be deposited into breast tissue during biopsy procedures. This may lead to tissue contamination or unintended complications during the procedure.

Who’s affected

Women who use the Brevera Breast Biopsy System disposable 9-gauge needle for breast biopsies are affected. Those with medical procedures using this specific needle are most at risk.

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.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall states particulates may deposit in breast tissue during use, but the official notice does not specify if this causes injury or serious harm.

How can I tell if I have the recalled product?

Check for the model number BREVDISP09 on the needle packaging. The recall includes all lots within the expiry date.

What should I do if I have the recalled product?

The recall does not specify a remedy, so the official notice does not state what action to take.

Take action

Contact Hologic

We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1314-2026 — Hologic Hologic

Hello,

I own a Hologic that is covered by recall Z-1314-2026 from Hologic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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.

Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Lower-risk recall