YelloPort Elite - Laparoscopic Port Access System recallZ-1396-2022 · Surgical Innovations Ltd · initiated Jun 2, 2022
Completed
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
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
FDA root cause category: Process change control
What the company is doing
On June 2, 2022, Surgical Innovation issued a "urgent Field Safety Notice. On 6/8/2022, Surgical Innovations issued an "updated: Urgent Medical Device Recall notification via E-Mail to provide additional information and a revised recall strategy. The updated communication, ask consignees to take the following actions: 1.Identify the devices and quarantine all stock. 2. All product still in stock at end users must be returned to the distributor. 3. Confirmation that all such stock has been returned and that any other product has been successfully used must be obtained by the distributor. 4. The distributor shall inform Surgical Innovations of the quantities and an RMA will be provided by Surgical Innovations for return off the product to Surgical Innovations. 5. The devices shall then be returned to Surgical Innovations of disposition and the Distributor compensated for the carriage fees. 6. Replacement devices, as appropriate, which do not have this issue, will be provided by Surgical Innovations.
Recall details
- Recall number
- Z-1396-2022
- Status
- Completed
- Initiated by the company
- Jun 2, 2022
- Recalling firm
- Surgical Innovations Ltd
- Product code
- GCJ
- FDA submissions
- K190592
- 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, Malaysia, Mexico, N. Ireland, Norway, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Dubai.
Product description
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Code information (models, lots, serial numbers)
All Lots; UDI/DI:05051986001562
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- YelloPort Elite - Laparoscopic Port Access System EA512USSurgical Innovations Limited · Laparoscope, General & Plastic Surgery1 recall0 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K190592 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- YelloPort Elite - Laparoscopic Port Access System ET1207503Surgical Innovations Limited · Laparoscope, General & Plastic Surgery1 recall1 report
- YelloPort Elite - Laparoscopic Port Access System EA10NHSurgical Innovations Limited · Laparoscope, General & Plastic Surgery1 recall0 reports
- YelloPort Elite - Laparoscopic Port Access System EA12NHSurgical Innovations Limited · Laparoscope, General & Plastic Surgery2 reports
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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