LivaNova Recalls Sterile Disposable Connectors Due to Incorrect Reducer Parts
LivaNova USA is recalling 140 sterile disposable connectors because some packages contained incorrect 3/8x1/4 reducers instead of the specified 1/2x1/2 connectors.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, and the source text explicitly states that no significant risk to health is expected because the defect is easily detectable and prevents use.
Plain-English summary
LivaNova USA Inc. is recalling 140 units of Sterile Disposable Connectors, 1/2x1/2, 20 units per case (Item# EC2135S, Lot No. 1923900091). The recall was initiated because some packages contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector.
The affected products were distributed to medical facilities in five states: Minnesota, Kansas, Missouri, Utah, and Washington. The FDA classifies this as a Class III recall, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
According to the source text, no significant risk to health is expected because the issue is easily detectable and the different shape of the incorrect part would prevent its use. Medical facilities should stop using the affected connectors and contact LivaNova USA Inc. for instructions on returning or disposing of the product.
The recalled product
- Product
- LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item# EC2135S
- Lot No. 1923900091
Distribution
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