[pending] Artelon FlexBand Plus Ref: 41054 & 41057
Pending LLM rewrite. Source: FDA_DEVICE Z-1555-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Augmentation devices failed bacterial endotoxin testing.
The recalled product
- Product
- Artelon FlexBand Plus Ref: 41054 & 41057
- Manufacturer
- International Life Sciences
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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