The U.S. Food and Drug Administration has issued a critical warning to healthcare providers about a significant and prolonged shortage of stereotactic breast biopsy needles, with disruptions expected to last until March 2027.
The shortage stems from recent supplier issues. Medical device maker Hologic initiated a recall of all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle on January 2nd, 2026, due to the risk of metal and plastic particles dislodging during use.
If left in the body, these particles could cause a foreign body reaction, hematoma, infection, or require an additional biopsy if they contaminate a tissue sample.
In response, the FDA is recommending healthcare providers implement needle conservation strategies. These include diversifying suppliers, using all available needle gauges and lengths, utilizing prior-generation devices where appropriate, and limiting unnecessary waste of the needles.
Clinicians are advised to communicate transparently with patients about potential delays, offer alternative biopsy locations if possible, and prioritize minimizing delays for cancer diagnosis and treatment.
The American College of Radiology has raised alarms, stating the shortages are creating "immediate and substantial challenges" for breast imaging practices nationwide, negatively impacting patient access to diagnostic care. The ACR is urging the FDA to expedite reviews of alternative devices and facilitate the temporary importation of comparable supplies to address this public health concern.