Z-0659-2025Class I

Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description...

Name: Z-0659-2025 Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description...
Creator: Kirwan Surgical Products, LLC
Published: 2024-11-14
License: https://open.fda.gov/license/

Kirwan Surgical Products, LLC / initiated 2024-11-14 / Open, Classified / root cause: design

FDA source

Kirwan Surgical Products, LLC began a recall of Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are... on 2024-11-14. FDA classified it as Class I and gives the reason as "Potential for the outer stainless-steel tube to break or detach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0659-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-11-14
Posted: 2024-12-16
Recalling firm: Kirwan Surgical Products, LLC
Product: 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 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential for the outer stainless-steel tube to break or detach.
Root cause tag: design
FDA root cause: Device Design
Action: Kirwan Surgical Products notified customers on 11/14/2024 via URGENT MEDICAL DEVICE RECALL letter. Customers were instructed to return any affected units, notify all customer if affected product was further distributed and request they return them, and complete and return the Response Form provided in the notification.
Quantity in commerce: 925 units
Distribution: Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.
Product codes and lots: Model/Catalog Number: 18241-0979. GTINs: Pouch - 00841019116623, Inner Pack - 10841019116620, Case - 20841019116627. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0659-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0654-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16
Z-0655-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16
Z-0656-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16
Z-0657-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16
Z-0658-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16
Z-0659-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16
Z-0660-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-16

Product code GEI

K864402Class IIBipolar Electrosurgical Intraocular ProbeNew England Surgical Instrument Corp. / cleared 1987-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)