LivaNova USA Inc.: Medical Device Recall in 2020 - (Recall #: Z-2461-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315

Product Classification:

Class II

Date Initiated: April 24, 2020

Date Posted: July 8, 2020

Recall Number: Z-2461-2020

Event ID: 85623

Reason for Recall:

The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

Status: Terminated

Product Quantity: 420 units

Code Information:

LOT 2004900016; 2002800193

Distribution Pattern:

US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)

Voluntary or Mandated:

Voluntary: Firm initiated