Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INTRABEAM Balloon Applicator Set Recalled by Carl Zeiss Meditec, Inc. Due to A manufacturing defect has been identified which could...
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
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Quantity: 36 total, all lots
Why Was This Recalled?
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
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