Recall Z-1006-2026— Sheathing Technologies Inc
Class II · Ongoing
Class II FDA medical device recall by Sheathing Technologies Inc, initiated 2025-11-17. It names one FDA 510(k) clearance: K153212. 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: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk..
- Recalling firm
- Sheathing Technologies Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-17
- Firm location
- Morgan Hill, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Data sourced from openFDA. This site is unofficial and independent of the FDA.