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 | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. |
| Product | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures. |
| Quantity | 19 |
| Distribution | US: MA |
| Initiated | 2022-01-20 |
| Classified | 2022-09-29 |
| Recall number | Z-1852-2022 |
| 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-1852-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90801/
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