Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BRAINLAB Curve Recalled by Brainlab AG Due to Incorrect manufacturer calibration

Date: July 16, 2020
Company: Brainlab AG
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Brainlab AG directly.

Affected Products

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

Quantity: 18 units

Why Was This Recalled?

Incorrect manufacturer calibration

Where Was This Sold?

This product was distributed to 3 states: CA, RI, TX

Affected (3 states)Not affected

About Brainlab AG

Brainlab AG has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report