Hologic, Inc
17 federal recalls on file, showing the 5 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Hologic, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-05-20FDA-DeviceClass IIHologic 3DIMENSIONS mammography systems recalled for loose bolts
Hologic's 3DIMENSIONS mammography systems may develop loose, missing, or broken internal bolts over time. This affects multiple model variants distributed nationwide. No injuries have been reported.
- 2026-05-20FDA-DeviceClass IIHologic Selenia Dimensions mammography systems recalled for loose bolts
Hologic has recalled multiple models of Selenia Dimensions mammography systems because internal bolts can become loose, missing, or broken over time. This may affect the system's structural integrity or function. No injuries have been reported.
- 2026-03-25FDA-DeviceClass IIStop 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.
- 2026-02-18FDA-DeviceClass IIStop 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.
- 2026-01-21FDA-DeviceClass IIStop 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.
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