# FDA recall Z-1554-2026

> **International Life Sciences** · Class II · device recall initiated 2026-02-06.

## Product

Artelon  FlexBand Dynamic Matrix  Ref: 31057

## 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.

## Key facts

- **Recall number:** Z-1554-2026
- **Recalling firm:** International Life Sciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-06
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1554-2026

## Citation

> AI Analytics. FDA recall Z-1554-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1554-2026. Source: US FDA. Licensed CC0.

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