Class IIOngoingZ-2168-2026
Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Hologic, IncMAMay 20, 2026
Hologic, Inc recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–6 of 6 recalls
Class IIOngoingZ-2167-2026
Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Hologic, IncMAMay 20, 2026
Class IIOngoingZ-1949-2026
Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco…
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.…
- Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
- Software design
Hologic, IncMAMay 6, 2026
Class IIOngoingZ-1314-2026
Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Hologic, IncMAFeb 18, 2026
Class IIOngoingZ-1093-2026
Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Fungal contamination of affected lot with Parengyodontium album.
Hologic, IncMAJan 21, 2026
Class IIOngoingZ-1170-2025
Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog N…
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Hologic, IncMAFeb 19, 2025