FDA recall Z-1006-2026

Sheathing Technologies Inc · Class II · device

Product

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.

Distribution

US Nationwide distribution in the state of WA.

Key facts

Status
Ongoing
Initiation date
2025-11-17
Report date
2026-01-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgan Hill, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2026