YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx… recallZ-1601-2023 · Surgical Innovations Ltd · initiated Mar 28, 2023
Open, Classified
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
Optical Trocars sterility assurance can not be guaranteed
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1601-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 28, 2023
- Posted by the FDA
- May 17, 2023
- Recalling firm
- Surgical Innovations Ltd
- Quantity
- 2380 units
- Product code
- GCJ
- FDA submissions
- K210495
- Distribution
- US: MA OUS: None
Product description
YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR
Code information (models, lots, serial numbers)
Lot # 738182 ; UDI-DI: (01) 05051986013398
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- YelloPort Elite EO0507005Surgical Innovations Limited · Laparoscope, General & Plastic Surgery1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92114).
- Z-1602-2023 · Open, ClassifiedYelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
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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