Agency classClass IIOur severity:High FDA (Devices)·Z-2765-2016·Announced 2016-09-14

Hologic Recalls SureSight Obturator Introducer Systems Due to Tip Breakage

Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (tip breakage) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hologic, Inc. is recalling 1,440 units of SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. The specific product model is ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece). The recall is due to a defect where the tip may break at the glue joint between the obturator body and the tip.

The affected products were distributed nationwide in the United States. The recall includes units with the following lot codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, and 605547.

Healthcare facilities and users should stop using the affected devices and contact Hologic, Inc. for instructions on how to return or replace the products.

The recalled product

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)
Manufacturer: Hologic, Inc
Category: Medical Device — MRI Localization System
Hazard: structural-defect
breakage
Affected units: 1,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hologic, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hologic, Inc

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