Quick Facts at a Glance
- Recall Date
- February 6, 2026
- Hazard Level
- HIGH
- Brand
- International Life Sciences
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- International Life Sciences
- Product type
- Augmentation devices
- Model numbers
- REF 41054, REF 41057
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 6, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Augmentation devices failed bacterial endotoxin testing.
What You Should Do
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
About This Product
Artelon FlexBand Plus is an augmentation device used in certain clinical settings. Consumers may encounter these devices in surgical or rehabilitative contexts.
Why This Is Dangerous
Endotoxin testing failure can indicate bioburden and biocompatibility issues potentially affecting patient safety.
Industry Context
This recall is part of ongoing FDA-regulated medical device recalls focusing on endotoxin compliance.
Real-World Impact
Immediate cessation required. Potential delays in treatment and need for alternate devices or procedures.
Practical Guidance
How to identify if yours is affected
- Check deviceRef REF 41054 and REF 41057
- Verify Lot numbers A10010201 and A10010101
- Review distribution list for your facility
Where to find product info
Recall letters and FDA enforcement page Z-1555-2026
What timeline to expect
Refund or replacement timelines are not specified
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a complaint with FDA if company is unresponsive
- Consult legal counsel if needed
How to prevent similar issues
- Ensure endotoxin testing during device sourcing
- Verify supplier recalls before implantation
- Maintain updated medical device recall alerts
Documentation advice
Keep recall notices, record device identifiers, dates, and communications with supplier
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Product Details
Product: Artelon FlexBand Plus. Ref: 41054 and 41057. Distribution: Worldwide, including US states listed and many countries. Recall date: 2026-02-06. Status: Active.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- Worldwide distribution including US and numerous countries
- Hazard: endotoxin testing failure
- High hazard level
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Safety Guide
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