SureSight Obturator Introducer Localization Systems — Class II medical device recall Z-2765-2016
Terminated recall by Hologic, Inc, reported 2016-09-14, distributed nationwide. Tip Breakage at the glue joint between the obturator body and tip
| Recall number | Z-2765-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2016-08-02 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,440 units |
| Reason classes | device malfunction |
| Lot numbers | 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547 |
| Model numbers | ATEC0914-20MR |
Product
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Reason for recall
Tip Breakage at the glue joint between the obturator body and tip
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-2765-2016. 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.