Hologic, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0351-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

Product Classification:

Class II

Date Initiated: July 7, 2017

Date Posted: January 24, 2018

Recall Number: Z-0351-2018

Event ID: 78777

Reason for Recall:

The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.

Status: Terminated

Product Quantity: 12 (U.S.)

Code Information:

UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165

Distribution Pattern:

US and OUS

Voluntary or Mandated:

Voluntary: Firm initiated