Hologic 3DIMENSIONS Mammography System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Hologic, Inc. is recalling 14,837 units of the 3DIMENSIONS Mammography System due to reports of loose, missing, or broken internal bolts.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Hologic, Inc. initiated a voluntary recall after receiving complaints of systems developing loose, missing, or broken internal bolts over time.
Which Products Are Affected
The recall affects 14,837 units of the 3DIMENSIONS MAMMOGRAPHY SYSTEM distributed nationwide in the United States. Affected model numbers 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 number is Z-2168-2026.
What You Should Do
Customers with questions should contact the recalling firm, Hologic, Inc., using the information provided with the recall notification.
Why This Matters
This Class II recall involves a device that may cause temporary or reversible adverse health consequences.
Source
FDA recall Z-2168-2026, Event ID 98566.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (871 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.