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Sheathing Technologies Inc: 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 Prob

Medical DevicesSource: FDA (device) · Date: 2026-01-07

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Sheathing Technologies Inc
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,
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of WA.
Recall initiated
2025-11-17
Code info
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Product quantity
12
Voluntary mandated
Voluntary: Firm initiated
City
Morgan Hill
State
CA
Country
United States
Event id
98068
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