SURESOUND22US Multipack — Class II medical device recall Z-0655-2017
Terminated recall by Hologic, Inc, reported 2016-11-30, distributed nationwide. Breach in sterile barrier compromising product sterility
| Recall number | Z-0655-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2016-10-28 |
| Classified | 2016-11-22 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, FI |
| Reason classes | sterility |
| Lot numbers | 16E25RB, 16E25RC, 16E25RD, 16F16R |
Product
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Reason for recall
Breach in sterile barrier compromising product sterility
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-0655-2017. 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.