The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2168-2026·Announced 2026-05-20

Hologic 3DIMENSIONS MAMMOGRAPHY SYSTEM medical device recall

Hologic is recalling certain 3DIMENSIONS MAMMOGRAPHY SYSTEM models due to internal bolts that may become loose, missing, or broken over time. The FDA classified this as a Class II recall.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as Class II, which typically warrants a score of 2-3. No reported injuries or hospitalizations are stated in the source text, and the hazard is a mechanical/structural issue rather than a high-risk pathogen or allergen. This meets the criteria for a Moderate (2) severity rating.

Plain-English summary

Hologic, Inc. is recalling the 3DIMENSIONS MAMMOGRAPHY SYSTEM, affecting approximately 14,837 units distributed nationwide. The recalled models include 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, and 3DM-SYS-STD-NS.

The recall was initiated following complaints that systems have developed loose, missing, or broken internal bolts over time. This issue affects the device's structural integrity.

Healthcare facilities and providers using these mammography systems should contact Hologic for inspection and repair guidance. The FDA has classified this recall as Class II (Recall Number Z-2168-2026).

The recalled product

Product
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.
Manufacturer
Hologic, Inc
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
14,837

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • "[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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hologic, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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