Hologic, Inc: Medical Device Recall in 2016 - (Recall #: Z-2765-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)

Product Classification:

Class II

Date Initiated: August 2, 2016

Date Posted: September 14, 2016

Recall Number: Z-2765-2016

Event ID: 74839

Reason for Recall:

Tip Breakage at the glue joint between the obturator body and tip

Status: Terminated

Product Quantity: 1440 units

Code Information:

Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated