Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

LivaNova USA Sterile Disposable Connector Recalled by LivaNova USA Inc. Due to Some packages of sterile disposable connectors contained a...

Date: November 18, 2019
Company: LivaNova USA Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova USA Inc. directly.

Affected Products

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

Quantity: 140 units

Why Was This Recalled?

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.

Where Was This Sold?

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

About LivaNova USA Inc.

LivaNova USA Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report