YelloPort Elite — Class II medical device recall Z-1602-2023
Ongoing recall by Surgical Innovations Ltd, reported 2023-05-24. Optical Trocars sterility assurance can not be guaranteed
| Recall number | Z-1602-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Surgical Innovations Ltd, Leeds, N/A, United Kingdom |
| Recall initiated | 2023-03-28 |
| Classified | 2023-05-17 |
| Reported by FDA | 2023-05-24 |
| Quantity | 3,405 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 05051986013428 |
| Lot numbers | 738182 |
| Model numbers | 5X95, EO0509505 |
Product
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Reason for recall
Optical Trocars sterility assurance can not be guaranteed
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-1602-2023. 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.