CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

3dimensions Mammography System recalled by Hologic

Hologic is recalling 3dimensions Mammography System, distributed nationwide in the US. The recall was initiated on 8 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes"[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.

Quantity recalled14837 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2168-2026
FDA event ID: 98566
Recalling firm: Hologic, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Apr 2026
FDA classified: 12 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 Apr 2026	Recall initiated by company
12 May 2026	Classified by FDA	+34 days
20 May 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Product as listed by the FDA

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Which lots are affected?

"[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.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98566

This product is part of a recall event; the main page for the event is Selenia Dimensions Mammography Systems recalled by Hologic.

Reported	Class	Recall	Company	Reason	Where
20 May 2026	CLASS II	Selenia Dimensions Mammography Systems recalled by Hologic	Hologic	Other	Nationwide

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