# FDA recall Z-1006-2026

> **Sheathing Technologies Inc** · Class II · device recall initiated 2025-11-17.

## 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 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.

## Distribution

US Nationwide distribution in the state of WA.

## Key facts

- **Recall number:** Z-1006-2026
- **Recalling firm:** Sheathing Technologies Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-17
- **Report date:** 2026-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgan Hill, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2026

## Citation

> AI Analytics. FDA recall Z-1006-2026. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1006-2026. Source: US FDA. Licensed CC0.

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