- Recalling firm
- Hologic, Inc
- Reason for recall
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Affected products (lot / model / serial)
- "[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.
- Units affected
- 14837 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Marlborough, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2168-2026
- Recall initiated
- April 8, 2026
- FDA classification date
- May 12, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98566
- Last updated on HTM Vibe
- July 24, 2026