Recall Z-1554-2026— International Life Sciences

Name: FDA recall Z-1554-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Class II · Ongoing

Class II FDA medical device recall by International Life Sciences, initiated 2026-02-06. It names 2 FDA 510(k) clearances: K230316, K200503. Product: Artelon FlexBand Dynamic Matrix Ref: 31057. Reason: Augmentation devices failed bacterial endotoxin testing..

Recalling firm: International Life Sciences
Classification: Class II
Status: Ongoing
Initiated: 2026-02-06
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K230316 — FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences·cleared 2023-05-26
K200503 — ATL AnchorsInternational Life Sciences·cleared 2020-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artelon FlexBand Dynamic Matrix Ref: 31057

Reason for recall

Augmentation devices failed bacterial endotoxin testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.