ACR urges FDA action on breast biopsy needle shortage

The American College of Radiology is urging federal action over an ongoing shortage of stereotactic breast biopsy needles.

In a May 14 update, ACR said it alerted federal officials to “patient care disruptions” tied to the shortage and sent a May 11 letter to the U.S. Food and Drug Administration calling for broader coordination.

FDA’s medical device shortage list identifies stereotactic breast biopsy needles as being in shortage, with availability estimated through Q4 2026. The agency lists the reason as a shortage or discontinuance of a device component, part, or accessory.

Image-guided breast biopsies are central to timely breast cancer diagnosis. ACR warned that continued shortages could delay evaluation of suspicious breast lesions, increase patient uncertainty, and add inefficiencies to already strained imaging workflows.

Dana H. Smetherman, MD, MBA, MPH, CEO of ACR, described the backlog as a “patient safety and public health concern,” particularly for high-volume centers and safety-net institutions.

Requested actions include expedited FDA review of alternative biopsy devices, improved communication with specialty societies, possible temporary importation pathways, and manufacturer engagement to prioritize biopsy supply. ACR also asked for coordination with the U.S. Department of Health and Human Services on contingency planning.

ACR said concerns about the shortage were raised during engagement sessions at ACR 2026, triggering its Quick Response Team process for supply chain issues.

A separate FDA recall entry shows Hologic initiated a Class 2 recall for Brevera Breast Biopsy System Disposable 9 Gauge Needles in December 2025, with the FDA posting the recall February 6, 2026. The listed recall reason was the presence of particulates that could be deposited into breast tissue during use.