LivaNova USA Sterile Disposable Connector — Class III medical device recall Z-2642-2020
Terminated recall by LivaNova USA Inc., reported 2020-07-29, distributed in KS, MN, MO, UT, WA. Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 co
| Recall number | Z-2642-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc., Arvada, CO, United States |
| Recall initiated | 2019-11-18 |
| Classified | 2020-07-17 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-08-19 |
| Distributed | KS, MN, MO, UT, WA |
| Quantity | 140 units |
| Reason classes | sterility |
| Lot numbers | 1923900091 |
| Model numbers | EC2135S |
Product
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2642-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.