Hologic, Inc recalls
16 federal recalls on file, showing the 4 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Hologic, Inc and put it in plain English.
Recent recalls
Hologic Selenia and 3Dimensions mammography systems recalled for loose boltsHologic is recalling 2 mammography system product lines, covering about 19,140 units nationwide. The company received complaints that internal bolts in these systems can become loose, missing, or broken over time. No injuries have been reported.
ModerateFDAMay 20, 20262 products
- Stop using Hologic Aptima HPV Assay kits
Hologic's Aptima HPV Assay test kits (Master Lot 929785) may produce invalid results or false negatives, meaning they could fail to detect HPV infection. The affected kits were distributed to healthcare facilities in California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, Puerto Rico, and Tennessee.
ModerateFDAMar 25, 2026
- Stop using Hologic Brevera biopsy needles
Hologic's Brevera Breast Biopsy System disposable 9 gauge needles may contain tiny particles that could be deposited into breast tissue during a biopsy procedure. This affects approximately 681,870 units distributed nationwide. No injuries have been reported so far.
ModerateFDAFeb 18, 2026
- Stop using Hologic ThinPrep CytoLyt Solution
Hologic's ThinPrep CytoLyt Solution (a buffered cell wash used in laboratory testing) from lot number 5062EC has been found to contain fungal contamination. The affected product was distributed nationwide. No injuries have been reported.
ModerateFDAJan 21, 2026