FDAFebruary 6, 2026device

Artelon FlexBand Plus Ref: 41054 & 41057

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Augmentation devices failed bacterial endotoxin testing.

What to do

FDA enforcement status: Ongoing

Brands named

international life sciencesinternationalinternational life

UPCs

0085000339606400850003396033

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Artelon FlexBand Plus Ref: 41054 & 41057 — Recall Details · AllClear