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Recall Observatory FDA recall evidence

Device 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,

Z-1006-2026

November 17, 2025

Class II

Product summary

Firm
Sheathing Technologies Inc
Event
Event 98068
Status
Ongoing
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-1006-2026

Official wording

Reason: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

Code information: UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01

Distribution pattern: US Nationwide distribution in the state of WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.