Hologic, Inc recalls

6 recalls.

• 3DIMENSIONS MAMMOGRAPHY SYSTEM recall (Hologic, Inc)
  Medical deviceClass IIReported May 20, 2026 · Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
• SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC recall (Hologic, Inc)
  Medical deviceClass IIReported May 20, 2026 · Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
• Brand Name: Genius" Review Station Product Name: Genius" Review Station Display recall (Hologic, Inc)
  Medical deviceClass IIReported May 6, 2026 · It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the...
• Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number:... recall (Hologic, Inc.)
  Medical deviceClass IIReported March 25, 2026 · Due to product exhibiting potential to generate either invalid or false negative results.
• Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Hologic, Inc)
  Medical deviceClass IIReported February 18, 2026 · Presence of particulates in affected devices that can be deposited into breast tissue during use.
• ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. recall (Hologic, Inc)
  Medical deviceClass IIReported January 21, 2026 · Fungal contamination of affected lot with Parengyodontium album.