WhichRecall
Class IIReported 2026-03-18

Artelon FlexBand Dynamic Matrix Ref: 31057

Recalled by International Life Sciences

Reason for Recall

Augmentation devices failed bacterial endotoxin testing.

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Recall Number
Z-1554-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-02-06
Reported
2026-03-18
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.
Code Info
A10011001/GTIN: 00850003396019
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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