Kirwan Surgical Bipolar Pencil Recalled Due to Potential Tube Breakage
Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. FDA Class I recalls require a minimum severity score of 4 per recall guidance. Although no deaths or serious injuries have been reported, the Class I designation reflects a reasonable probability of serious adverse health consequences from structural failure of a surgical instrument during use.
Plain-English summary
Kirwan Surgical Products LLC is recalling its Disposable 25-gauge Bipolar Pencil, Model 14-5011L, a surgical instrument designed for eye surgery and other soft tissue procedures, including cauterization of the retinal area. The product has a molded handle with a 25-gauge outer diameter tip.
The outer stainless-steel tube of the pencil may break or detach during surgical use. This potential structural failure creates a safety hazard during procedures.
A total of 66 units with sterile Lot Number 221020 were distributed worldwide, including to the United States, Puerto Rico, Australia, Canada, Chile, Colombia, Denmark, Egypt, England, France, Germany, Israel, Italy, Japan, Mexico, the Netherlands, the Philippines, South Africa, Switzerland, Taiwan, Thailand, Trinidad, Turkey, the United Arab Emirates, and Venezuela. The recalled lot includes all units with expiration dates of September 1, 2027 or later.
The recalled product
- Product
- 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 in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for…
- Manufacturer
- Kirwan Surgical Products, LLC
- Hazard
- Affected units
- 66
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model/Catalog Number: 14-5011L. GTINs: Pouch - 00841019101056
- Inner Pack - 10841019101053
Distribution
Part of a larger recall action
This product is one of 7 recalled by Kirwan Surgical Products, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Kirwan Surgical Products, LLC
See all →- SevereWalcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment
FDA (Devices) · 2024-12-25
- SevereNidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk
FDA (Devices) · 2024-12-25
- SevereOptikon Bipolar Pencil surgical tool recalled for tube failure risk
FDA (Devices) · 2024-12-25
- SevereAmbler Surgical Bipolar Pencil recalled for outer tube structural failure
FDA (Devices) · 2024-12-25
- SevereSurgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery
FDA (Devices) · 2024-12-25
Same hazard · breakage
See all →- ModeratePapablic Replacement Brush Heads Recalled for Potential Breakage
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- SevereMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits Containing Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
Similar recalls
- HighOphthalmic Surgical Knives Recalled Due to Sharpness Defect
FDA (Devices) · 2024-08-28
- HighGenicon GENILook Cannula Recalled Due to Potential Tip Detachment
FDA (Devices) · 2020-06-17
- HighAlcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness
FDA (Devices) · 2024-08-28
- HighGenicon GENILook Medical Device Recalled for Potential Tip Detachment
FDA (Devices) · 2020-06-17
- HighOphthalmic surgical knives recalled due to reported sharpness defects
FDA (Devices) · 2024-08-28
- HighGenicon GENILook Cannula Recalled for Potential Tip Detachment
FDA (Devices) · 2020-06-17