Official recall record
Disposable Bipolar Pencil 25GA Straight
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Kirwan Surgical Products LLC is conducting a voluntary recall of all 25-gauge Disposable Bipolar Pencils with a sterile lot range from 220906 to 241002 labeled with an expiration date of September 1st, 2027 or later. Serious injury may occur due to the failure mode associated with this recall. One case of serious injury has been reported in which the filament protective sheath came off when the surgeon removed the instrument from the right eye. The sheath stayed in the eye and poked a hole in the retina. Medical intervention prevented permanent damage. Recall Start Date: November 13, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.