Recall Record

Sarasota, FL, United States

ASO LLC recalls

4 recalls recorded since 2018, most recently on 23 March 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
23 March 2023
Reason
The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.
Distribution
US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI
Initiated
Voluntary: Firm initiated
Recall number
Z-1499-2023

Ongoing Class II Medical devices

Recall started
22 June 2022
Reason
The product falls apart during handling after removal from its primary packaging.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX, and VA. The country of Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-1517-2022

Terminated Class II Medical devices

Recall started
2 March 2022
Terminated
12 June 2024
Reason
Kits contained recalled acetaminophen.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-1031-2022

Ongoing Class II Medical devices

Recall started
16 October 2018
Reason
Potential that gauze pads may not be fully sterilized
Distribution
Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
Initiated
Voluntary: Firm initiated
Recall number
Z-0525-2019

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.