Sheathing Technologies Inc recalls Sheathes3D Seamless Viral Barrier

Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

On 11/17/2025, recall notices were emailed to customers asked to do the following: 1) Quarantine products subject to recall. 2) This recall should be carried out to the user level. 3) Complete and return the response form via email to Gretcheno@sheathes.com

• FDA enforcement recordOfficial FDA database entry for Z-1006-2026
• FDA 510(k) clearance · K153212The device's official FDA premarket clearance record
• FDA device classification · ITXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Sheathing Technologies IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.