YelloPort Plus - Laparoscopic Port Access System recallZ-1853-2022 · Surgical Innovations Ltd · initiated Jan 20, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Surgical Innovations Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
FDA root cause category: Process control
What the company is doing
On 01/20/2022, Urgent Field Safety Notices were emailed to customers who were asked to do the following: 1) Quarantine affected devices and return to the recalling firm. 2) If the devices are no longer in stock, confirm whether devices were used clinically, and if so, whether the devices were sterilized in accordance with the Instructions for Use prior to use. 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices were transferred. 4) Complete response form. The recalling firm provided the following email: [email protected]
Recall details
- Recall number
- Z-1853-2022
- Status
- Open, Classified
- Initiated by the company
- Jan 20, 2022
- Posted by the FDA
- Sep 29, 2022
- Recalling firm
- Surgical Innovations Ltd
- Quantity
- 1
- Product code
- GCJ
- FDA submissions
- K070712
- Distribution
- US: MA
Product description
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Code information (models, lots, serial numbers)
Part/UDI-DI/Lot: YC0507001/05051986001890/735652
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- YelloPort Plus - Laparoscopic Port Access System YC0507001Surgical Innovations Limited · Laparoscope, General & Plastic Surgery1 recall1 report
Product lines
Other devices under the same FDA submission
6 devices cleared under K070712 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- YelloPort Plus - Laparoscopic Port Access System YA05VSS01Surgical Innovations Limited · Laparoscope, General & Plastic Surgery4 reports
- YelloPort Plus - Laparoscopic Port Access System YA512STSASurgical Innovations Limited · Laparoscope, General & Plastic Surgery3 reports
- YelloPort Plus - Laparoscopic Port Access System YC0515010Surgical Innovations Limited · Laparoscope, General & Plastic Surgery2 reports
- YelloPort Plus - Laparoscopic Port Access System YC0507011Surgical Innovations Limited · Laparoscope, General & Plastic Surgery1 report
- YelloPort Plus - Laparoscopic Port Access System YC0509501Surgical Innovations Limited · Laparoscope, General & Plastic Surgery1 report
- YelloPort Plus - Laparoscopic Port Access System YC1210522Surgical Innovations Limited · Laparoscope, General & Plastic Surgery1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 90801).
- Z-1852-2022 · Open, ClassifiedProduct/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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