Recall Record

Harrisburg, NC, United States

Safeguard US Operating LLC recalls

2 recalls recorded since 2018, most recently on 2 September 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
2 September 2026
Reason
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
Distribution
Worldwide - US Nationwide distribution including in the states of FL, OK, CA, WA, GA, TX, PA, IL, MD, NC, OR, DE, NJ, MI, RI, AR, WI, AZ, CO, IN, MO, OH, MA, NY, VA, KY, UT, NM, SC, TN, LA, AL, MN, MT, AK, WV, KS, NE, WY, MS, HI, NH, IA, DC, CT and the countries of BRA, BEL, SGP, AUS.
Initiated
Voluntary: Firm initiated
Recall number
Z-0081-2027

Ongoing Class II Medical devices

Recall started
27 August 2024
Reason
Incorrect expiration date.
Distribution
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-3182-2024, Z-3181-2024, Z-3183-2024

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.