FDA Medical Device Recalls (openFDA)
Surgical Innovations Ltd: Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
- Recall number
- Z-1853-2022
- Recalling firm
- Surgical Innovations Ltd
- Product
- Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
- Status
- Open, Classified
- Initiated
- 2022-01-20
- Posted
- 2022-09-29
- Terminated
- not on file
- Reason
- Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
- Root cause
- Process control
- Action
- 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: quality@surginno.co.uk
- Quantity
- 1
- Distribution
- US: MA
- Lot, serial or model codes
- Part/UDI-DI/Lot: YC0507001/05051986001890/735652
- 510(k) numbers
- ["K070712"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3002808173
- Firm city
- Leeds
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28