Class II — Hologic, Inc
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Breach in sterile barrier compromising product sterility |
| Product | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound |
| Quantity | 600 units (US) ; 24 units (OUS) |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria. |
| Initiated | 2016-10-28 |
| Classified | 2016-11-22 |
| Terminated | 2017-08-18 |
| Recall number | Z-0655-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc (Z-0655-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75558/
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