3DIMENSIONS MAMMOGRAPHY SYSTEM — Class II medical device recall Z-2168-2026
Ongoing recall by Hologic, Inc, reported 2026-05-20, distributed nationwide. Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
| Recall number | Z-2168-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2026-04-08 |
| Classified | 2026-05-12 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 14,837 units |
| UPC / GTIN / UDI-DI | 15420045510524, 15420045510531, 15420045510548, 15420045510555, 15420045510562, 15420045510579, 15420045510586, 15420045510593, 15420045510609 |
| Serial numbers | 3DIMENSIONS |
| 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 |
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.
Reason for recall
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2168-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.