FDA Medical devices recall ·
Sheathes3D Seamless Viral Barrier, Latex-Free… recall
- Recall number
- Z-1006-2026
- Date
- (initiated November 17, 2025)
- Company / brand
- Sheathing Technologies Inc
675 Jarvis Dr, Morgan Hill, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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,
Why was it recalled?
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Distribution
US Nationwide distribution in the state of WA.
States: Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1006-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.