Leeds, N/A, United Kingdom
Surgical Innovations Ltd recalls
3 recalls recorded since 2018, most recently on 28 March 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 March 2023
- Reason
- Optical Trocars sterility assurance can not be guaranteed
- Distribution
- US: MA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1602-2023, Z-1601-2023
- YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
- YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Completed Class II Medical devices
- Recall started
- 2 June 2022
- Reason
- There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IN, WA, MA and the countries of Armenia, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Ecuador, UK, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Ma
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1396-2022
- YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Ongoing Class II Medical devices
- Recall started
- 20 January 2022
- Reason
- Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
- Distribution
- US: MA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1853-2022, Z-1852-2022
- Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
- Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.