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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Brevera Breast Biopsy Disposable Needles Recalled for Particulate Contamination

Agency Publication Date: February 6, 2026
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Summary

Hologic, Inc. is recalling approximately 681,870 Brevera Breast Biopsy System Disposable 9 Gauge Needles due to the presence of particulates in the devices. These particulates can be unintentionally deposited into breast tissue during biopsy procedures. This recall affects all lots that are currently within their expiration dates.

Risk

Small particles may be left behind in the breast tissue during a biopsy, which could lead to inflammation, infection, or the need for additional medical intervention to remove the foreign material.

What You Should Do

  1. Identify if you have the Brevera Breast Biopsy System Disposable 9 Gauge Needle by checking the packaging for Model Number BREVDISP09 and UDI 1540045512863.
  2. Check the expiration date on the product label; all lots currently within their expiry date are affected by this recall.
  3. Stop using the recalled device immediately.
  4. Contact Hologic, Inc. or your distributor to arrange for the return, replacement, or correction of the affected needles.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Brevera Breast Biopsy System Disposable 9 Gauge Needle
Variants: 9 Gauge
Model / REF:
BREVDISP09
UDI:
1540045512863
Date Ranges: All Lots within expiry

Biopsy Instrument

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98172
Status: Active
Manufacturer: Hologic, Inc
Sold By: Medical distributors; Direct from manufacturer
Manufactured In: United States
Units Affected: 681,870 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.