1/4X3/16X3/16YCONN — Class II medical device recall Z-2458-2020
Terminated recall by LivaNova USA Inc., reported 2020-07-08, distributed in AK, AR, AZ, CA, CO, CT, DC, DE…. The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connecto
| Recall number | Z-2458-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA Inc., Arvada, CO, United States |
| Recall initiated | 2020-04-24 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2022-02-17 |
| Distributed | AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | ES |
| Quantity | 20 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00803622129278 |
| Lot numbers | 2004900015 |
Product
1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
Reason for recall
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
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-2458-2020. 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.