Quick Facts at a Glance
- Recall Date
- December 15, 2025
- Hazard Level
- HIGH
- Brand
- Hologic
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Hologic
- Product type
- Breast Biopsy System
- Model numbers
- Model No - BREVDISP09, UDI - 1540045512863, All Lots within expiry.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of particulates in affected devices that can be deposited into breast tissue during use.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Brevera Breast Biopsy System is a medical device used for breast biopsies. It aids in the accurate sampling of breast tissue for diagnostic purposes.
Why This Is Dangerous
The device has been found to contain particulates that can enter breast tissue during a biopsy, posing potential health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients are advised to stop using the device immediately, which may lead to delays in necessary medical procedures.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Check for the UDI number on the packaging.
- Confirm the device is within the recalled lot.
Where to find product info
Model numbers and UDI can typically be found on the device packaging or in the user manual.
What timeline to expect
Expect a response from Hologic within 4-6 weeks for refund processing.
If the manufacturer is unresponsive
- Contact Hologic customer service again.
- Document all communications regarding the recall.
- Consider reporting to the FDA if unresponsive.
How to prevent similar issues
- Look for FDA recall alerts on medical devices.
- Check for safety certifications before purchasing medical devices.
- Consult healthcare professionals about device safety.
Documentation advice
Keep a record of any communication regarding the recall, including emails and letters from the manufacturer.
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Product Details
The Brevera Breast Biopsy System includes a Disposable 9 Gauge Needle. Model numbers affected are BREVDISP09 and UDI 1540045512863. The devices were distributed nationwide.
Key Facts
- Potential contamination hazard
- Patients advised to stop using immediately
- Contact manufacturer for instructions
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Safety Guide
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