LivaNova USA Inc.: Medical Device Recall in 2020 - (Recall #: Z-2642-2020)

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:

LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

Product Classification:

Class III

Date Initiated: November 18, 2019

Date Posted: July 29, 2020

Recall Number: Z-2642-2020

Event ID: 85858

Reason for Recall:

Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

Status: Terminated

Product Quantity: 140 units

Code Information:

Item# EC2135S, Lot No. 1923900091

Distribution Pattern:

Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.

Voluntary or Mandated:

Voluntary: Firm initiated