Hologic, Inc recalls

All Hologic, Inc recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (12).

12 recalls published between December 4, 2024 and May 20, 2026. Most common issues: microbial contamination (1), sterility (1), injury risk (1). 1 was FDA Class I, the most serious level.

• 3DIMENSIONS MAMMOGRAPHY SYSTEM recall
  FDA May 20, 2026 · Hologic, Inc · Class II
• SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers:… recall
  FDA May 20, 2026 · Hologic, Inc · Class II
• Genius" Review Station Product Name: Genius" Review Station Display (Barco… recall
  FDA May 6, 2026 · Hologic, Inc · Class II
• Aptima HPV Assay Product Name: Aptima HPV Assay Model recall
  FDA March 25, 2026 · Hologic, Inc · Class II
• Brevera Breast Biopsy System Disposable 9 Gauge Needle recall
  FDA February 18, 2026 · Hologic, Inc · Class II
• ThinPrep¿ CytoLyt¿ Solution recall
  FDA January 21, 2026 · Hologic, Inc · Class II
• Sertera Biopsy Device Product Name: Sertera Biopsy Device Model recall
  FDA February 19, 2025 · Hologic, Inc · Class II
• The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of… recall
  FDA February 12, 2025 · Hologic, Inc · Class II
• Panther Fusion GBS Assay recall
  FDA January 22, 2025 · Hologic, Inc · Class II
• Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay recall
  FDA January 1, 2025 · Hologic, Inc · Class II
• Hologic Sizer Set- sterilization tray and 6 individual sizers… recall
  FDA December 18, 2024 · Hologic, Inc · Class II
• BioZorb Marker recall
  FDA December 4, 2024 · Hologic, Inc · Class I