Recall Record

Paramus, NJ, United States

Touch US Llc recalls

1 recall recorded since 2018, most recently on 21 June 2022. 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
21 June 2022
Reason
Device was marketed without FDA 510(k) clearance or a PMA.
Distribution
US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Initiated
Voluntary: Firm initiated
Recall number
Z-1461-2022

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.