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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

International Life Sciences Augmentation Devices Recalled for Endotoxin Failure

Agency Publication Date: March 11, 2026
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Summary

International Life Sciences is recalling several models of Artelon FlexBand augmentation devices, including the FlexBand Dynamic Matrix, FlexBand Plus, and FlexBand Twist, because they failed bacterial endotoxin testing. While no injuries have been reported, these medical devices are used in surgical procedures and must meet strict safety standards for contaminants. These products were distributed worldwide and across the United States between February and March 2026.

Risk

Bacterial endotoxins can cause a severe inflammatory response, fever, or infection when introduced into the body during surgery, potentially leading to surgical complications or the need for additional medical intervention.

What You Should Do

  1. Stop using the recalled Artelon FlexBand devices immediately.
  2. Check your inventory for Artelon FlexBand Dynamic Matrix (Ref 31057), FlexBand Plus (Ref 41054 & 41057), and FLEXBAND TWIST (Ref TW012).
  3. Identify affected products by checking the lot numbers and GTIN codes on the packaging. See the Affected Products section below for the full list of affected codes.
  4. Contact International Life Sciences or your distributor to arrange for the return, replacement, or correction of any affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Artelon FlexBand Dynamic Matrix
Model / REF:
31057
Lot Numbers:
A10011001
GTIN:
00850003396019

Recall #: Z-1554-2026

Product: Artelon FlexBand Plus
Model / REF:
41054
41057
Lot Numbers:
A10010201
A10010101
GTIN:
00850003396064
00850003396033

Recall #: Z-1555-2026

Product: Artelon FLEXBAND TWIST .12
Variants: 3.85x17mm HEX Anchor (Qty 2), 5.0x17mm HEX Anchor (Qty 1), 0.5x12cm FLEXBAND (Qty 1)
Model / REF:
TW012
Lot Numbers:
RK29976
GTIN:
00850003396248

Recall #: Z-1556-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98399
Status: Active
Manufacturer: International Life Sciences
Sold By: Authorized distributors; Surgical centers; Hospitals
Manufactured In: United States
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.