FDA Device recall Z-2080-2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product De…
- FDA Device
- Class I
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class I recall of Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product De… by Edwards Lifesciences, citing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2080-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-14 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.
Reason
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Identifiers
| code_info | Lot Code: Model No:OPTI16; UDI: 00690103180558; All lots up to BSLC9149 Serial Numbers: 130467 130471 130602 130765 130…Lot Code: Model No:OPTI16; UDI: 00690103180558; All lots up to BSLC9149 Serial Numbers: 130467 130471 130602 130765 130816 130822 130852 130949 131039 131041 131044 131237 131312 131428 131509 131826 131887 131908 132338 132436 132503 132831 BSLC0040 BSLC0165 BSLC0165 BSLC0320 BSLC1309 BSLC1309 BSLC1468 BSLC1468 BSLC1557 BSLC1682 BSLC1688 BSLC1825 BSLC1830 BSLC5302 BSLC5899 BSLC6166 BSLC7142 BSLC7142 BSLC7513 BSLC8176 BSLC8659 BSLC9149 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2080-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.