Dive Brief:
- The Food and Drug Administration has reported 252 injuries were associated with Hologic’s BioZorb radiographic markers implanted in the breast and other soft tissue sites during medical procedures. No deaths were reported.
- The update comes almost two years after Hologic told customers to stop using the devices due to reports of adverse events such as pain, infection and device migration. At the time, Hologic said it had received 188 complaints associated with adverse events.
- In its latest communication, the FDA repeated Hologic’s instructions advising healthcare providers not to use the BioZorb markers. Patients should be monitored for signs of adverse events, but Hologic said there is no need to have an implanted marker removed from the body.
Dive Insight:
Following the recall, Hologic received a warning letter from the FDA in December 2025. The agency found the company failed to meet design requirements for the markers and raised concerns about corrective and preventive processes.
Hologic stopped shipping the markers in September 2024 and no longer manufactures the devices.
Hologic is also grappling with a Class II device recall of its biopsy needles. The company removed all lots of Brevera 9 gauge needles from the market in January due to a risk that metal and plastic particles could become deposited in breast tissue during the procedure. The issue has led to a shortage of biopsy needles.
Blackstone and TPG acquired Hologic in April, taking the company private in a deal valued at up to $18.3 billion. Former Baxter leader José Almeida was named Hologic’s CEO when the deal closed, and Steve MacMillan retired after more than a decade at the helm.
