Quick Facts at a Glance
- Recall Date
- February 6, 2026
- Hazard Level
- HIGH
- Brand
- International Life Sciences
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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 device
- Model numbers
- A10011001/GTIN: 00850003396019
- Sold at
- Multiple Retailers
- 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
The Artelon FlexBand Dynamic Matrix is described as an augmentation device intended for tissue support in surgical procedures.
Why This Is Dangerous
The recall is due to endotoxin testing failure in the augmentation device, which could pose infection-related risks if implanted.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall could affect patients relying on this device and may require medical consultation and potential device replacement or monitoring.
Practical Guidance
How to identify if yours is affected
- Check the model number A10011001/GTIN: 00850003396019
- Review labeling for the model identifier
- Consult your surgeon or healthcare provider if you have this device
Where to find product info
FDA recall page and manufacturer letters; see also the recall URL above
What timeline to expect
Not specified by the recall; follow manufacturer communications
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer and clinician
- If you cannot obtain guidance, contact FDA recall info for escalation
How to prevent similar issues
- Ensure any future implants are from manufacturers with transparent endotoxin testing and recall processes
- Ask providers about endotoxin testing and device safety during implantation
- Keep up with manufacturer updates and patient safety notices
Documentation advice
Retain recall letters, model numbers, serial numbers, and all correspondence with providers and the manufacturer
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Product Details
Model numbers: A10011001/GTIN: 00850003396019 Where sold: Worldwide distribution including US states 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; countries Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model A10011001/GTIN: 00850003396019
- Global distribution including US and listed countries
- Endotoxin testing failure in Artelon FlexBand Dynamic Matrix 31057
- Recall date: 2026-02-06; Status: ACTIVE
- Brand: International Life Sciences
- Replacement or refund specifics not provided
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Safety Guide
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