Hologic, Inc: Medical Device Recall in 2016 - (Recall #: Z-0655-2017)

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:

SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound

Product Classification:

Class II

Date Initiated: October 28, 2016

Date Posted: November 30, 2016

Recall Number: Z-0655-2017

Event ID: 75558

Reason for Recall:

Breach in sterile barrier compromising product sterility

Status: Terminated

Product Quantity: 600 units (US) ; 24 units (OUS)

Code Information:

Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB

Distribution Pattern:

Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.

Voluntary or Mandated:

Voluntary: Firm initiated