SX-One MicroKnife Recalled for Potential Dull Blade Defect
Sonex Health LLC is recalling approximately 3,752 SX-One MicroKnife surgical instruments nationwide due to potential blade dulling that may compromise proper function.
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: This is an FDA Class II recall of a surgical instrument with a functional defect that poses a risk of harm if the dull blade compromises surgical performance. No illnesses or injuries have been reported, placing this in the High severity tier for risk-of-harm products without reported adverse outcomes.
Plain-English summary
Sonex Health LLC is recalling the SX-One MicroKnife, a surgical cutting instrument distributed nationwide across 26 U.S. states. The recall affects approximately 3,752 devices identified by Part Number 600112-001 and specific lot codes.
The product is being recalled due to potential dull blade defect. A dull blade may compromise the instrument's ability to function as intended during surgical procedures.
The affected devices were distributed across Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Indiana, Kansas, Maryland, Michigan, Minnesota, Montana, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, Wisconsin, West Virginia, and Wyoming.
Healthcare providers and patients who have received this product should contact the manufacturer for guidance on handling the affected devices.
The recalled product
- Product
- SX-One MicroKnife
- Manufacturer
- SONEX HEALTH LLC
- Hazard
- dull-blade
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 (20)
- Part Number 600112-001
- UDI-DI: 00860002094700
- Lot Codes: 20013120
- 20022821
- 20022822
- 20022823
- 20022824
- 20022825
- 20070603
- 20070604
- 20080435
- 20080436
- 20083114
- 20083115
- 40051
- 40052
- 40472
- 40473
- 40892
- 40893
Distribution
Distributed nationwide across the United States.
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