Class III — LivaNova USA Inc.
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| Product | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case |
| Quantity | 140 units |
| Distribution | Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington. |
| Initiated | 2019-11-18 |
| Classified | 2020-07-17 |
| Terminated | 2021-08-19 |
| Recall number | Z-2642-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — LivaNova USA Inc. (Z-2642-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85858/
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