Hologic, Inc Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy recall: Presence of particulates in affected devices that can be deposited
Presence of particulates in affected devices that can be deposited into breast tissue during use.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Presence of particulates in affected devices that can be deposited into breast tissue during use.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-1314-2026
- Published
- February 18, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Hologic, Inc
- Product type
- Medical devices
- Units affected
- 681,870 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
- UPC codes
- 1540045512863
Products covered by this recall
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Check your product
The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 1540045512863
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- within expiry. — 681
- 870 units
Model or item number
On the rating label, the box or the instruction sheet.
- No - BREVDISP09
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Hologic, Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Hologic, Inc — 250 Campus Dr, Marlborough, MA, 01752-3020
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Hologic, Inc medical devices recalled?
Presence of particulates in affected devices that can be deposited into breast tissue during use. Presence of particulates in affected devices that can be deposited into breast tissue during use.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 1540045512863; lot code within expiry. — 681, 870 units; model number No - BREVDISP09. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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