CLASS I ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
The Disposable Microsurgical Bipolar Pencil are designed recalled
Kirwan Surgical Products is recalling The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and, distributed nationwide in the US. The recall was initiated on 14 Nov 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0660-2025
- FDA event ID
- 95753
- Recalling firm
- Kirwan Surgical Products, Marshfield, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 14 Nov 2024
- FDA classified
- 16 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 14 Nov 2024 | Recall initiated by company | |
| 16 Dec 2024 | Classified by FDA | +32 days |
| 25 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the outer stainless-steel tube to break or detach.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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, 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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential for the outer stainless-steel tube to break or detach.
Which lots are affected?
Model/Catalog Number: OPT14-5011. Lot Code: J20499-01, J21637-01, J21999-01, J21995-01, J22003-01, J23738-01, J23739-01, J23740-01, J23743-01, J24697-01, J24710-01, J24711-01, J26812-01, J30100-01. Component, no UDI held by Kirwan Surgical Products.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 95753More recalls from Kirwan Surgical Products
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Disposable 25-gauge bipolar pencil, straight recalled | Kirwan Surgical Products | Device Malfunction | Nationwide |
| Device | CLASS I | Accutome/Microsurgical Disposable Bipolar Pencil Straight recalled | Kirwan Surgical Products | Device Malfunction | Nationwide |
| Device | CLASS I | The Disposable Microsurgical Bipolar Pencil are designed recalled | Kirwan Surgical Products | Device Malfunction | Nationwide |
| Device | CLASS I | Ambler Surgical Bipolar Pencil Straight recalled | Kirwan Surgical Products | Device Malfunction | Nationwide |
| Device | CLASS I | Disposable 25-gauge bipolar pencil, straight, Long recalled | Kirwan Surgical Products | Device Malfunction | Nationwide |
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