LivaNova USA: Medical Device Recall in 2018 - (Recall #: Z-1901-2018)

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:

Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

Product Classification:

Class II

Date Initiated: April 20, 2018

Date Posted: May 30, 2018

Recall Number: Z-1901-2018

Event ID: 80072

Reason for Recall:

Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.

Status: Terminated

Product Quantity: 2408

Code Information:

Serial #: a) 16S10743 - 6S11708 b) 16S10772 - 16S16840 C) 16S10958 - 16S16847

Distribution Pattern:

MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,

Voluntary or Mandated:

Voluntary: Firm initiated