The FDA has posted 6 enforcement recalls from Hologic, Inc since 2025, none of them Class I (most serious). Most recent report: May 20, 2026.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings.…
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Fungal contamination of affected lot with Parengyodontium album.
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Firm name as filed with the FDA: “Hologic, Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.