Z-1852-2022Class II

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor...

Name: Z-1852-2022 Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor...
Creator: Surgical Innovations Ltd
Published: 2022-01-20
License: https://open.fda.gov/license/

Surgical Innovations Ltd / initiated 2022-01-20 / Open, Classified / root cause: manufacturing process

FDA source

Surgical Innovations Ltd began a recall of Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures on 2022-01-20. FDA classified it as Class II and gives the reason as "Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1852-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-20
Posted: 2022-09-29
Recalling firm: Surgical Innovations Ltd
Product: Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Root cause tag: manufacturing process
FDA 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: [email protected]
Quantity in commerce: 19
Distribution: US: MA
Product codes and lots: Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1852-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1852-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29
Z-1853-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29

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)