FDA Device recall Z-1602-2023
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR by Surgical Innovations, citing optical Trocars sterility assurance can not be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1602-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-28 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Surgical Innovations |
| Distribution | MA |
Product
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Reason
Optical Trocars sterility assurance can not be guaranteed
Identifiers
| code_info | Lot # 738182 ; UDI-DI: (01) 05051986013428 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1602-2023%22
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