Hologic (HOLX) is recalling its BioZorb and BioZorb LP implantable markers due to complications and adverse events reported with implanted devices, the US Food and Drug Administration said Tuesday.
The FDA said it has identified this recall as the most serious type, adding that continued use of the devices may lead to serious injury or death.
There have been 252 reported injuries, the regulator said, adding that there have been no reports of death.
The firm sent an urgent medical device recall letter on Oct. 24, 2024, with recommended actions, and later issued a follow-up notification on April 6, 2026, providing updated guidance, it said.
Hologic didn't immediately reply to MT Newswires' request for comment.
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