Xstar Kojo slit knife recalled for incorrect blade orientation
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
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: Class II device with a blade configuration defect that presents a risk of harm during surgical use. No illnesses or injuries have been reported, meeting the rubric criteria for High severity as a risk-of-harm product where injury has not yet been documented.
Plain-English summary
Beaver Visitec International, Inc., is recalling one lot of the Xstar Kojo Safety Slit Knife, Part Number 373025, 2.5mm 45° bevel up. A total of 2160 units from lot 6049877 (UDI-DI: 30886158000373) have been identified as defective.
The recalled knives incorrectly contain a bevel down blade instead of the specified bevel up blade. This configuration error could affect blade performance and handling during surgical procedures.
The affected units were distributed internationally, including to Japan. The recall impacts surgical centers and medical facilities that received units from lot 6049877.
Customers who have received units from the affected lot should stop use immediately and contact Beaver Visitec International, Inc., for guidance on replacement or return.
The recalled product
- Product
- Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- incorrect-blade-orientation
- surgical-risk
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: 30886158000373
- Lot Number: 6049877
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03