FDA Medical devices recall ·
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0654-2025
- Date
- (initiated November 14, 2024)
- Company / brand
- Kirwan Surgical Products, LLC
180 Enterprise Dr, Marshfield, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 80,060 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Why was it recalled?
Potential for the outer stainless-steel tube to break or detach.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Sterile Lot Range: 220906 to 241002. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
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.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0654-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.