FDA Recall
Open, Classified
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
·
Initiated November 17, 2025
Recall
- Recall Number
- Z-1006-2026
- Event Number
- 98068
- Firm
- Sheathing Technologies Inc
- FEI Number
- 1000135740
- Product Code
- ITX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 17, 2025
- Posted
- December 31, 2025
- Address
- 675 Jarvis Dr, Morgan Hill, CA, 95037-2815
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.
Action
On 11/17/2025, recall notices were emailed to customers asked to do the following: 1) Quarantine products subject to recall. 2) This recall should be carried out to the user level. 3) Complete and return the response form via email to [email protected]
Distribution
US Nationwide distribution in the state of WA.
Quantity
12