Z-1396-2022Class II

YelloPort Elite Universal Seal. For use in laparoscopic procedures

Name: Z-1396-2022 YelloPort Elite Universal Seal. For use in laparoscopic procedures
Creator: Surgical Innovations Ltd
Published: 2022-06-02
License: https://open.fda.gov/license/

Surgical Innovations Ltd / initiated 2022-06-02 / Completed / root cause: packaging

FDA source

Surgical Innovations Ltd began a recall of YelloPort Elite Universal Seal. For use in laparoscopic procedures on 2022-06-02. FDA classified it as Class II and gives the reason as "There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1396-2022
Classification: Class II
Status: Completed
Initiated: 2022-06-02
Posted: 2022-07-18
Recalling firm: Surgical Innovations Ltd
Product: YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: packaging
FDA root cause: Process change control
Action: 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.
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 codes and lots: All Lots; UDI/DI:05051986001562

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2022	Class II	Completed	Voluntary: Firm initiated	2022-07-27	2022-07-18

Product code GCJ

K190592Class IIYelloPort Elite Port Access SystemSurgical Innovations Limited / cleared 2019-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)