Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tape... (Sheathing Technologies Inc) – vaginal/rectal ultrasound probe cover... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
Sheathing Technologies Inc
Lot Codes / Batch Numbers
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Products Sold
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
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 7.4 due to Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infectio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026