FDAFDA · Food and drugs·Recall number Z-1554-2026
Artelon FlexBand Dynamic Matrix Ref: 31057
Published March 18, 2026 · Recall initiated: February 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Augmentation devices failed bacterial endotoxin testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- International Life Sciences
- Distributor
- 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.
- Lot
- A10011001/GTIN: 00850003396019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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