Food, drugs, devices › Surgical Innovations Ltd
Device recall: YelloPort Elite Universal Seal. For use in laparoscopic procedures.
FDA enforcement event 90447 is a device recall by Surgical Innovations Ltd of Leeds, N/A, initiated 2 Jun 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Surgical Innovations Ltd has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Surgical Innovations Ltd, Leeds, N/A, United Kingdom.
Reason for recall
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1396-2022 | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | N/A | Class II | Completed | 27 Jul 2022 |
Context
Other enforcement events for Surgical Innovations Ltd
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Mar 2023 | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | Device | Class II | 2 |
| 20 Jan 2022 | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use i | Device | Class II | 2 |
All 3 events for Surgical Innovations Ltd
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.