Sheathing Technologies Inc: Device Recall
Recall #Z-1006-2026 · 11/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1006-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Sheathing Technologies Inc
- Status
- Ongoing
- Date Initiated
- 11/17/2025
- Location
- Morgan Hill, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
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.
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,
Distribution Pattern
US Nationwide distribution in the state of WA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.