FDA-Device2026-01-07Class IIPROCESSING DEFECT
Sheathes3D ultrasound probe covers recalled for potential product defects and infection risk
What this means
Sheathes3D Seamless Viral Barrier ultrasound probe covers may have manufacturing defects that could allow contamination during medical use. This poses a risk of infection to patients. The recall affects a limited quantity distributed in Washington State.
- Stop using affected probe covers (Item Number 76339, Lot 25-45)
- Contact your supplier or Sheathing Technologies Inc for instructions on replacement or return
- Check your inventory against the lot number and expiration date (2028-11-01)
- Do not use covers with visible damage or defects
The agency's original wording
Hazard
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of WA.
Affected count
12
Manufactured in
675 Jarvis Dr, N/A, Morgan Hill, CA, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2026Want us to check the next one for you?
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