Reported Mar 18, 2026 · Ongoing

Artelon FlexBand Plus Ref: 41054 & 41057

International Life Sciences

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: International Life Sciences · 8601 Dunwoody Pl Ste 250 · Atlanta, GA · 30350-2513

Is this the product you have?

  • Artelon FlexBand Plus Ref41054 & 41057
Lot codes and dates
  • REF41054 -Lot:
  • A10010201/GTIN00850003396064
  • REF41057 -
  • LotA10010101/GTIN: 00850003396033
Amount recalled
N/A

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Augmentation devices failed bacterial endotoxin testing.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.