Reported Dec 25, 2024 · Ongoing

Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable…

Kirwan Surgical Products, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Kirwan Surgical Products, LLC · 180 Enterprise Dr · Marshfield, MA · 02050-2110

Optikon Bipolar Pencil 25 Gauge Straight
Model/Catalog NumberOPT14-5011
Product DescriptionThe Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge

Lot codes and dates: Model/Catalog NumberOPT14-5011
Lot Code
J20499-01
J21637-01
J21999-01
J21995-01
J22003-01
J23738-01
J23739-01
J23740-01
J23743-01
J24697-01
J24710-01
J24711-01
J26812-01
J30100-01. Component
no UDI held by Kirwan Surgical Products
Amount recalled: 2,999 units

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Stop using this product now

Potential for the outer stainless-steel tube to break or detach.

Using this product could cause serious injury, illness or death — stop using it now.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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