Z-1006-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 7, 2026
- Initiation Date
- November 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
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.
Distribution Pattern
US Nationwide distribution in the state of WA.
Code Information
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01