Destino Twist and Guidestar Devices Recalled for Potential Threaded Component Separation
Oscor Inc. is recalling 549 units of Destino Twist and Guidestar devices due to potential separation between the threaded hub and cap. Affected devices were distributed in Tennessee, Pennsylvania, and the Czech Republic.
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 is an FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard—potential separation between threaded components—represents a risk of harm, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported, which scores 3 (High).
Plain-English summary
Oscor Inc. is recalling Destino Twist 14F and Guidestar 14F devices due to potential for separation between the threaded hub and threaded cap at the proximal end of the device. The recall affects 549 total units distributed across multiple lot numbers.
Affected devices were distributed to healthcare facilities in Tennessee and Pennsylvania in the United States, and to the Czech Republic internationally. Specific lot numbers, models, and UDI codes for the recalled devices are available through the FDA.
Healthcare professionals and facilities in possession of these devices should review the recall notice for specific lot identifiers and contact Oscor Inc. with any questions.
The recalled product
- Product
- Destino Twist 14F (also branded as Guidestar 14F)
- Manufacturer
- Oscor Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 549
Distribution
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