Class II — Surgical Innovations Ltd
| Recalling firm | SURGICAL INNOVATIONS PLC |
|---|---|
| Registered facility | SURGICAL INNOVATIONS LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Optical Trocars sterility assurance can not be guaranteed |
| Product | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR |
| Quantity | 3405 units |
| Distribution | US: MA OUS: None |
| Initiated | 2023-03-28 |
| Classified | 2023-05-17 |
| Recall number | Z-1602-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Surgical Innovations Ltd (Z-1602-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92114/
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