SureSight Obturator Introducer Localization Systems — Class II medical device recall Z-2766-2016

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-2766-2016`
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	535 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	`ATEC0914-12MR`

Product

SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

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-2766-2016. 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.