FDANovember 14, 2024device
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for the outer stainless-steel tube to break or detach.
What to do
FDA enforcement status: Ongoing
Brands named
kirwan surgical productskirwankirwan surgical
UPCs
008410191010491084101910104620841019101043
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAFarm Rich Pizza Cheese Crunchers2026-05-19
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
- FDABrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV...2026-04-24
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