FDA Enforcement
Class II
Ongoing
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,
Recall: Z-1006-2026
·
Reported January 7, 2026
Enforcement
- Recall Number
- Z-1006-2026
- Event ID
- 98068
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sheathing Technologies Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 7, 2026
- Initiation Date
- November 17, 2025
- Classification Date
- December 31, 2025
- Address
- 675 Jarvis Dr, N/A, Morgan Hill, CA, 95037-2815, United States
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
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Code Info
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Distribution
US Nationwide distribution in the state of WA.
Quantity
12