Recall Record

Morgan Hill, CA, United States

Sheathing Technologies Inc recalls

1 recall recorded since 2018, most recently on 17 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
17 November 2025
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.
Distribution
US Nationwide distribution in the state of WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-1006-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.