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,
This recall is currently active, issued December 31, 2025. It was issued by Sheathing Technologies Inc.
- Company
- Sheathing Technologies Inc
- Recall Initiated
- November 17, 2025
- Posted
- December 31, 2025
- Recall Number
- Z-1006-2026
- Quantity
- 12
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Distribution
US Nationwide distribution in the state of WA.
Lot / Code Info
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Root Cause
Process control
Action Taken
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 Gretcheno@sheathes.com