Sheathing Technologies recalled 12 units of its ultrasound probe covers on November 17, 2025, due to potential contamination risks. The non-sterile vaginal and rectal covers may have defects that pose an infection risk during use. Consumers should stop using the product immediately and follow the manufacturer's instructions.
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Sheathing Technologies Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Sheathes3D Seamless Viral Barrier, a latex-free ultrasound probe cover, measuring 7/8"D tapered to 2.9"W x 11.8"L. The product is sold in a box of 50 under item number 76339, with a UDI-DI of 10842418100975. The lot number is 25-45 and it expires on November 1, 2028.
These ultrasound probe covers may have defects that increase the risk of contamination during use. This issue poses a potential infection risk for patients undergoing vaginal or rectal ultrasound procedures.
There have been no reported incidents related to injuries or infections caused by the defect at this time.
Stop using the ultrasound probe covers immediately. Follow the recall instructions provided by the manufacturer and contact Sheathing Technologies Inc or your healthcare provider for further guidance.
For more information, contact Sheathing Technologies Inc. Visit the FDA website for details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1006-2026.
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