Class II — Sheathing Technologies Inc
| Recalling firm | SHEATHING TECHNOLOGIES, INC. |
|---|---|
| Registered facility | SHEATHING TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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, |
| Quantity | 12 |
| Distribution | US Nationwide distribution in the state of WA. |
| Initiated | 2025-11-17 |
| Classified | 2025-12-31 |
| Recall number | Z-1006-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sheathing Technologies Inc (Z-1006-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98068/
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