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Lower risk Medical device recall · FDA · Published March 28, 2023

Surgical Innovations YelloPort Elite Optical Trocar Recall: Sterility Risk

Surgical Innovations recalls YelloPort Elite 5x95 Optical Trocars due to unguaranteed sterility. Affected units have specific lot numbers and UDI-DI codes. Consumers should check their product details to determine if recalled.

🇺🇸 FDA recall #Z-1602-2023Medical deviceSurgical Innovations ›
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Recalling firmSurgical Innovations Ltd6 Clayton Wood Bank, Lds · Leeds, United Kingdom
✎ GovInfoNow plain-language explainer

Surgical Innovations is recalling YelloPort Elite 5x95 Optical Trocars because the sterility assurance cannot be guaranteed. This means the devices might not be sterile, posing a risk of infection during medical procedures. Read more at govinfonow.com/recall/58638-surgical-innovations-yelloport-elite-optical-trocar-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58638-surgical-innovations-yelloport-elite-optical-trocar-recall-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1602-2023

Cite this page

“Surgical Innovations YelloPort Elite Optical Trocar Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58638-surgical-innovations-yelloport-elite-optical-trocar-recall-sterility-risk. Based on FDA recall #Z-1602-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1602-2023%22&limit=1).

The FDA announced on March 28, 2023, that Surgical Innovations Ltd voluntarily recalled YelloPort Elite Optical Trocars due to sterility assurance risks. The agency issued recall number Z-1602-2023 for the Class II device distributed in Massachusetts.

How to tell if you have it

  • Brand: Surgical Innovations
  • Product: YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
  • UPC: 05051986013428
  • Lot Code: 738182
  • Units affected: 3405

The hazard

The recall addresses the risk that sterility assurance cannot be guaranteed for the optical trocars. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Surgical Innovations Ltd has two other recalls on record since January 20, 2022. On June 2, 2022, the company recalled YelloPort Elite Universal Seals due to packaging sterility risks. Other recent recalls of similar products include Argon Medical Devices One-Piece Introducer Tray Recall (June 1, 2026), Argon Medical Devices General Biospy Tray Recall (June 1, 2026), and Argon Medical Devices: Transvenous Pacing Electrode Tray Recall Due to Sterility Risk (June 1, 2026).

How to tell if you have this one

Check for the lot number 738182 and UDI-DI code (01) 05051986013428 on the product packaging. These items are sold under the brand name YelloPort Elite with the reference number EO0509505.

  • Brand
    Surgical Innovations
  • Product
    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US: MA OUS: None
Recall numberProduct, codes & lotsQuantity
Z-1601-2023YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR; Lot # 738182 ; UDI-DI: (01) 050519860133982380 units
Z-1602-2023YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR; Lot # 738182 ; UDI-DI: (01) 050519860134283405 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 738182 and UDI-DI code (01) 05051986013428 on the packaging to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed in Massachusetts.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US: MA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Massachusetts.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: Mar 28, 202312. FDA classified it Class II: May 17, 202323. Published in FDA’s Enforcement Report: May 24, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1602-2023 (March 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1602-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA