FDA says recalled Hologic biopsy needles are in short supply
The agency warned doctors to conserve breast biopsy needles after a Hologic recall tied to reports of fragments left in patients.
By Sofia Marchetti · World Affairs Correspondent
3 min read
The Food and Drug Administration says the U.S. is short of breast biopsy needles after Hologic Inc. recalled products used to collect tissue from suspicious breast lesions. The shortage could slow breast cancer diagnosis, and the agency said supply disruptions may continue until March 2027.
The FDA advised health care providers to conserve available needles while the market adjusts. Hologic said it is working with the FDA and the American College of Radiology and is trying to bring the recalled needles back to market by the end of 2026.
Recall followed reports of fragments left behind
Hologic began the recall in January after reports that metal and plastic pieces could break loose from the needles and remain in patients, according to the company’s customer notice. Hologic said then that an internal review covering nearly 700,000 needles over three years found 108 complaints.
The devices are stereotactic breast biopsy needles, which doctors use to remove tissue from areas flagged as suspicious. The Cleveland Clinic says stereotactic biopsy systems use imaging guidance and a vacuum-assisted needle to collect samples for testing.
Hologic said in its January customer letter that retained particles could cause infection, delay diagnosis or interfere with MRI scans. The company also said some patients might need additional procedures to remove fragments.
The FDA has received about 20 adverse event reports since the start of this year involving Hologic’s biopsy system. Reports described cases including a plastic piece protruding from a biopsy site, plastic beads emerging from biopsy sites and a patient later finding that a lump was a 4-centimeter piece of plastic tube along the biopsy path, according to the agency’s records cited in the report.
Radiologists warn of diagnostic delays
The American College of Radiology told the FDA in a May letter that the shortage was creating “immediate and substantial” problems for breast imaging practices across the country. Dana Smetherman, the group’s chief executive, wrote that limited needle supplies could delay diagnosis, increase uncertainty and force some patients into more invasive diagnostic procedures, including surgery.
Hologic said it plans interim steps while the recall remains in effect. The company said those steps include enabling standalone imaging, increasing supplies of other needle products, speeding product deliveries and stabilizing inventory.
Hologic is a major supplier of women’s health imaging and diagnostic devices, including mammography machines, biopsy guidance systems and metal marker clips used to identify biopsy sites. Its breast-health business generates about $1.5 billion in annual sales, according to the company information cited in the report.
The company was acquired in April by funds managed by Blackstone Inc. and TPG Inc., according to the report.
Hologic has faced other safety-related recalls. Bloomberg previously reported that the company’s BioZorb implant was recalled in 2024 after hundreds of women said the device did not dissolve in their breasts and was linked to infections and severe pain.
BioZorb was intended to help patients heal after lumpectomy, a breast-conserving surgery to remove tumors, according to Bloomberg’s prior reporting. Bloomberg reported that some patients needed additional surgeries, including mastectomies, and that Hologic for years did not report many complaints to the FDA within the 30-day period required under federal law.
This story draws on original reporting from Fortune.