Surgical Knife Crescent Recall Due to Incorrect Blade Angle
Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: This surgical instrument defect creates a risk of harm during surgical procedures. No injuries have been reported, placing this within FDA Class II criteria at the maximum severity score of 3 per the editorial rubric.
Plain-English summary
Beaver Visitec International is recalling one lot of Conventional Knife Crescent 2.5mm surgical instruments due to incorrect blade orientation. The affected lot (Number 6054027) contains blades with bevel-down configuration, whereas these instruments are manufactured to have a bevel-up angle of 55 degrees.
This defect affects blade orientation during surgical use. The affected instruments were distributed internationally to healthcare facilities in Belgium, China, France, Germany, Greece, Italy, Jordan, Lithuania, Netherlands, Oman, Poland, Spain, and Sweden.
Healthcare providers who received instruments from the identified lot should discontinue use immediately. Organizations should verify their inventory against the provided lot number (6054027) and UDI-DI (30886158000571). Contact Beaver Visitec International for instructions on return or replacement of affected instruments.
The recalled product
- Product
- Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 1,980
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)
- UDI-DI: 30886158000571
- Lot Number: 6054027
Distribution
Distribution scope not specified by the agency.
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