Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX Recalled by Carl Zeiss Meditec, Inc. Due to Due to failure to acquire pre-market clearance for...
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 Carl Zeiss Meditec, Inc. directly.
Affected Products
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Quantity: 914 systems
Why Was This Recalled?
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Carl Zeiss Meditec, Inc.
Carl Zeiss Meditec, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report