International Life Sciences recalled Artelon FlexBand Plus augmentation devices after endotoxin testing failures. The recall affects devices with REF 41054 and REF 41057 distributed worldwide. Patients and healthcare providers must stop using the devices immediately and follow manufacturer instructions for recall return.
Augmentation devices failed bacterial endotoxin testing.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact International Life Sciences or your healthcare provider for instructions. Notification method: Letter
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Artelon FlexBand Plus is an augmentation device used in certain clinical settings. Consumers may encounter these devices in surgical or rehabilitative contexts.
Endotoxin testing failure can indicate bioburden and biocompatibility issues potentially affecting patient safety.
This recall is part of ongoing FDA-regulated medical device recalls focusing on endotoxin compliance.
Immediate cessation required. Potential delays in treatment and need for alternate devices or procedures.
Recall letters and FDA enforcement page Z-1555-2026
Refund or replacement timelines are not specified
Keep recall notices, record device identifiers, dates, and communications with supplier
Product: Artelon FlexBand Plus. Ref: 41054 and 41057. Distribution: Worldwide, including US states listed and many countries. Recall date: 2026-02-06. Status: Active.
No specific injuries or incidents are reported in the provided data.
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