Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Dis
Summary
The FDA issued a Class I for Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 182 by Kirwan Surgical Products, LLC. Reason: Potential for the outer stainless-steel tube to break or detach..
Details
Source
Device Recall
External ID
Z-0659-2025
Action Date
2024-12-25
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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.
Quantity Affected: 925 units
Reason for Recall
Potential for the outer stainless-steel tube to break or detach.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-14
Company
Marshfield, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Kirwan Surgical Products, LLC has 8 FDA actions in our database, including 7 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kirwan Surgical Products, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kirwan Surgical Products, LLC have FDA actions?
Kirwan Surgical Products, LLC has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0659-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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