Artelon FlexBand Dynamic Matrix recall: Endotoxin
Artelon FlexBand Dynamic Matrix Ref: 31057
Why was Artelon FlexBand Dynamic Matrix recalled?
Augmentation devices failed bacterial endotoxin testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
A10011001/GTIN: 00850003396019
- Product
- Artelon FlexBand Dynamic Matrix Ref: 31057
- Recalling firm
- International Life Sciences
- Quantity
- N/A
- Distribution
- Worldwide - US Nationwide distribution including in the states of 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 and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
- Recall date
- March 18, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)