Recall Z-1006-2026
Sheathing Technologies Inc · initiated November 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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,
Codes / lots: UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
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.
FDA-determined 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
Details
- Recall number
- Z-1006-2026
- Initiated
- November 17, 2025
- Posted by FDA
- December 31, 2025
- Product code
- ITX – Transducer, Ultrasonic, Diagnostic
- Quantity
- 12
- Distribution
- US Nationwide distribution in the state of WA.
- Recalling firm
- Sheathing Technologies Inc, Morgan Hill, CA