Sheathes3D Seamless Viral Barrier recalled over sterility concerns

Recall date

November 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sheathing Technologies Inc recalls 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-Ste…

Recall number

Z-1006-2026

FDA classification

Class II

Brand / firm

Sheathing Technologies Inc

Sold / distributed

US Nationwide distribution in the state of WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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,