Recall Record

Charlotte, NC, United States

SVS LLC recalls

2 recalls recorded since 2018, most recently on 13 May 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
13 May 2024
Reason
Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
Distribution
US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
Initiated
Voluntary: Firm initiated
Recall number
Z-2320-2024

Terminated Class II Medical devices

Recall started
1 October 2018
Terminated
13 July 2020
Reason
This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.
Distribution
US distribution to OH, NY,TX, PA
Initiated
Voluntary: Firm initiated
Recall number
Z-0487-2019

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.