--- title: "Kirwan Surgical Products, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Kirwan Surgical Products, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/kirwan-surgical-products-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Kirwan Surgical Products, LLC recall records **7** reported ongoing 7 records in this archive. Latest source date Nov 14, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Nov 14, 2024 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-0654-2025-kirwan-surgical-products-llc-disposable-25-gauge-bipolar-pencil-straight-model-catalog-number-14-501/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0654-2025%22) Nov 14, 2024 FDA device enforcement ### [Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use ...](https://isitonrecall.com/recall/fda-device-z-0655-2025-kirwan-surgical-products-llc-disposable-25-gauge-bipolar-pencil-straight-long-model-catalog-number-1/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Nu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0655-2025%22) Nov 14, 2024 FDA device enforcement ### [Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use...](https://isitonrecall.com/recall/fda-device-z-0656-2025-accutome-microsurgical-disposable-bipolar-pencil-5-in-12-7cm-25-gauge-straight-model-catalog-number/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0656-2025%22) Nov 14, 2024 FDA device enforcement ### [Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft t...](https://isitonrecall.com/recall/fda-device-z-0657-2025-ambler-surgical-bipolar-pencil-25-gauge-straight-model-catalog-number-pd7226-the-disposable-microsur/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Mi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0657-2025%22) Nov 14, 2024 FDA device enforcement ### [Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, ...](https://isitonrecall.com/recall/fda-device-z-0658-2025-walcott-bipolar-pencil-25-gauge-straight-model-catalog-number-rx14-5011-product-description-the-disp/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: T...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0658-2025%22) Nov 14, 2024 FDA device enforcement ### [Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in...](https://isitonrecall.com/recall/fda-device-z-0659-2025-nidek-co-disposable-bipolar-pencil-25-gauge-straight-model-catalog-number-18241-0979-product-descrip/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0659-2025%22) Nov 14, 2024 FDA device enforcement ### [Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery,...](https://isitonrecall.com/recall/fda-device-z-0660-2025-optikon-bipolar-pencil-25-gauge-straight-model-catalog-number-opt14-5011-product-description-the-dis/) Potential for the outer stainless-steel tube to break or detach. Class I Reported ongoing Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPP... [Official source for Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0660-2025%22) ## Reasons in these listed records - Potential for the outer stainless-steel tube to break or detach. These examples come from this result page and are not a ranking of every recall reason. ## Checking Kirwan Surgical Products, LLC ### Is there a recall on kirwan surgical products, llc right now? This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Kirwan Surgical Products, LLC](https://isitonrecall.com/check/?q=Kirwan%20Surgical%20Products%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)