Breast biopsy needles recalled over particulates that can enter tissue
Hologic is recalling 681,870 Brevera Breast Biopsy System disposable 9 gauge needles because particulates in affected devices can be deposited into breast tissue during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states particulates can be deposited into breast tissue during use, and no injuries are reported.
Plain-English summary
The Brevera Breast Biopsy System Disposable 9 Gauge Needle, a biopsy instrument, is being recalled by Hologic, Inc.
The reason given in the enforcement record is the presence of particulates in affected devices that can be deposited into breast tissue during use.
The record lists 681,870 units under model number BREVDISP09, UDI 1540045512863, covering all lots within expiry. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
Particulate deposited into tissue during a biopsy is a contamination hazard. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Hologic's instructions.
The recalled product
- Product
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Manufacturer
- Hologic, Inc
- Category
- Medical Device — Biopsy needle
- Affected units
- 681,870
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No - BREVDISP09
- UDI - 1540045512863
- All Lots within expiry.
Distribution
Distributed nationwide across the United States.
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