Sheathes3D Seamless Viral Barrier recall (Sheathing Technologies Inc)
Medical deviceClass IIOngoing
Summary: Sheathing Technologies Inc is recalling 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.
What is being recalled
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,
Why
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of WA. (states named: Washington)
How to tell if yours is affected
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1006-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 17, 2025 |
| Reported | January 7, 2026 |
| Company | Sheathing Technologies Inc |
| Company location | Morgan Hill, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 |
More recalls from Sheathing Technologies Inc · all medical device recalls · recalls from November 2025