International Life Sciences recalls Artelon FlexBand Plus Ref: 41054 & 41057

Recall date

February 6, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1555-2026

FDA classification

Class II

Brand / firm

International Life Sciences

Sold / distributed

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea,…

Why it was recalled

Augmentation devices failed bacterial endotoxin testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Artelon FlexBand Plus Ref: 41054 & 41057