Beaver Visitec Safety Sideport Knife Blades May Detach During Surgery
Beaver Visitec is recalling Safety Sideport Knives because blades may fall out of handles due to non-cured epoxy. The defect poses a risk during ophthalmic surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (loose blades) that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Beaver Visitec is recalling 1,354 units of the Safety Sideport Knife 1.0mm 45° (REF 378210). The recall is due to a manufacturing defect where the blades are loose in the handles and may fall out because of non-cured epoxy.
The affected products are indicated to make stab incisions during ophthalmic surgery. The recall covers units distributed nationwide in California, Iowa, Colorado, Hawaii, Maryland, and Texas. The specific lot numbers involved are 6002436 and 6002663.
Healthcare facilities and consumers should stop using these knives immediately. Users should contact Beaver Visitec for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
- Manufacturer
- Beaver Visitec
- Affected units
- 1,354
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 (1)
- Lot Numbers: 6002436 & 6002663
Distribution
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