Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to ...
FDA Recall #Z-1006-2026 — Class II — November 17, 2025
Product Description
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Reason for Recall
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Recalling Firm
Sheathing Technologies Inc — Morgan Hill, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12
Distribution
US Nationwide distribution in the state of WA.
Code Information
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated