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Home › FDA recalls › Sheathes3D Seamless Viral Barrier
CLASS II · ModerateFDA

Sheathing Technologies Inc recalls Sheathes3D Seamless Viral Barrier

📅 Nov 17, 2025 · 📍 Nationwide
Recalling company
Sheathing Technologies Inc
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
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 17, 2025
Reported
Jan 7, 2026
Distribution
US Nationwide distribution in the state of WA.
Status
Ongoing
Quantity
12
Lot / codes
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Company location
Morgan Hill, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-1006-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1006-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.