Summary
The FDA issued a Class II for Artelon FlexBand Plus Ref: 41054 & 41057 by International Life Sciences. Reason: Augmentation devices failed bacterial endotoxin testing..
Details
Source
Device Recall
External ID
Z-1555-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Artelon FlexBand Plus Ref: 41054 & 41057
Lot/Code Info: REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
Quantity Affected: N/A
Reason for Recall
Augmentation devices failed bacterial endotoxin testing.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-06
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
International Life Sciences has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (International Life Sciences) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does International Life Sciences have FDA actions?
International Life Sciences has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1555-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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