FDAHealthNovember 17, 2025
Sheathing Technologies Inc — 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, Tapere
⚠️ Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 17, 2025
US Nationwide distribution in the state of WA.
What's affected?
- 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,
- Lot code
- 25-45
Additional details
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12.
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