Recall Z-1556-2026— International Life Sciences

Name: FDA recall Z-1556-2026
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 TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1). 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 TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Reason for recall

Augmentation devices failed bacterial endotoxin testing.

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