Grandbrothers The U.S. Food and Drug Administration (FDA) on Wednesday categorized Hologic’s ( NASDAQ: HOLX ) decision to recall its implantable radiographic marker, BioZorb, as a Class I recall, the agency’s most serious type of recall.
In March, the MedTech company started to recall more than 53K units of BioZorb Markers distributed from April 29, 2019, to April 1, 2024, following reports of complications and adverse events. BioZorb Marker, a device used to mark breast and other soft tissues for future medical procedures, such as radiation, was linked to 71 injuries, the FDA noted. There were no deaths.
“The FDA is working with Hologic Inc. to evaluate all available information about the safety of BioZorb Marker and BioZorb LP Marker devices and to address potential risks when used in breast tissue,” the regulator noted. The product recall comes at a time when Hologic ( HOLX ) is facing multiple lawsuits in Massachusetts over injury claims linked to BioZorb.
More on Hologic Hologic: Women's Health Play Looks Healthier Itself Hologic, Inc. (HOLX) Q2 2024 Earnings Call Transcript Hologic Non-GAAP EPS of $1.03 beats by $0.
05, revenue of $1.02B beats by $20M Hologic Q2 2024 Earnings Preview Seeking Alpha’s Quant Rating on Hologic.