Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula… — Class I medical device recall Z-2083-2025
Ongoing recall by Edwards Lifesciences, LLC, reported 2025-07-16, distributed nationwide. due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body
| Recall number | Z-2083-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2025-05-14 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CO, CY, CZ, DE, DK, ES, FR, GB, GR, HU, IE, IL, IN, IS, IT, JP, KR, LU, MT, MX, MY, NL, NO, PA, PK, PL, PT, RO, SE, SG, SK, TH, TW, ZA |
| Quantity | 847 |
| UPC / GTIN / UDI-DI | 00060913168341 |
| Lot numbers | BSLC1689 |
| Serial numbers | FEMII016AS |
| Model numbers | 0060913168341, BSLC1689, FEMII016AS |
Product
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
Reason for recall
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
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-2083-2025. 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.