Z-1602-2023Class II

YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

Name: Z-1602-2023 YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Creator: Surgical Innovations Ltd
Published: 2023-03-28
License: https://open.fda.gov/license/

Surgical Innovations Ltd / initiated 2023-03-28 / Open, Classified / root cause: sterility

FDA source

Surgical Innovations Ltd began a recall of YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR on 2023-03-28. FDA classified it as Class II and gives the reason as "Optical Trocars sterility assurance can not be guaranteed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1602-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-28
Posted: 2023-05-17
Recalling firm: Surgical Innovations Ltd
Product: YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Optical Trocars sterility assurance can not be guaranteed
Root cause tag: sterility
FDA root cause: Other
Action: On March 29, 2023, Surgical Innovations issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. An update to the communication was sent on 4/17/2023 to affected consignees via E-Mail. In addition to informing consignees about the recall, Surgical Innovations ask consignees to take the following action: 1. Distributor should confirm receipt of this Field Safety Notice 2. Identify the devices held in stock at the distributor and quarantine affected batches awaiting further instruction. 3. Issue this Field Safety Notice to all end users (Hospital) that the distributor has supplied 4. All product still in stock at the end users must be returned to the distributor. 5. Confirmation must be obtained by the distributor that either all stock has been returned or that any other product has been successfully used. 6. Confirmation to Surgical Innovations using the attached form of this disposition of all stock 7. Await further instruction from Surgical Innovations regarding further action for the affected products.
Quantity in commerce: 3405 units
Distribution: US: MA OUS: None
Product codes and lots: Lot # 738182 ; UDI-DI: (01) 05051986013428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1602-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1601-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17
Z-1602-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-17

Product code GCJ

K210495Class IIPort Access SystemSurgical Innovations Limited / cleared 2021-06-18

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)