FDA Medical Device Recalls (openFDA)
Surgical Innovations Ltd: YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
- Recall number
- Z-1602-2023
- Recalling firm
- Surgical Innovations Ltd
- Product
- YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
- Status
- Open, Classified
- Initiated
- 2023-03-28
- Posted
- 2023-05-17
- Terminated
- not on file
- Reason
- Optical Trocars sterility assurance can not be guaranteed
- 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
- 3405 units
- Distribution
- US: MA OUS: None
- Lot, serial or model codes
- Lot # 738182 ; UDI-DI: (01) 05051986013428
- 510(k) numbers
- ["K210495"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3002808173
- Firm city
- Leeds
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28