Brevera Breast Biopsy System Disposable 9 Gauge Needle. recall: Particulate Matter
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Why was Brevera Breast Biopsy System Disposable 9 Gauge Needle. recalled?
Presence of particulates in affected devices that can be deposited into breast tissue during use.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
- Product
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Recalling firm
- Hologic, Inc
- Quantity
- 681,870 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 18, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)