Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect
Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.
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: The recall involves a medical device with a manufacturing defect that could lead to a component failure during use. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carl Zeiss Meditec, Inc. is recalling 36 units of the INTRABEAM Balloon Applicator Set, 3.5 cm. The product is intended for radiation therapy treatments and was distributed nationwide, including in Illinois and Maryland.
The recall was initiated due to a manufacturing defect that could result in a small tube becoming dislodged between the luer fitting and the check valve. The affected units have part number 304534-7500-001 and lot number 540959.
Healthcare facilities and consumers should stop using the affected INTRABEAM Balloon Applicator Sets and contact the recalling firm for further instructions.
The recalled product
- Product
- INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Hazard
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part number 304534-7500-001
- lot number 540959.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Carl Zeiss Meditec, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Carl Zeiss Meditec, Inc.
See all →- ModerateCIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation
FDA (Devices) · 2022-03-16
- ModerateCIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance
FDA (Devices) · 2021-08-18
- HighCarl Zeiss PLEX Elite 9000 Recalled for Electrical Shock Hazard
FDA (Devices) · 2020-01-08
- HighVisuMax Software Recall for Incorrect Corneal Cut Type During Suction Loss
FDA (Devices) · 2019-12-25
- HighZeiss IOLMaster Recalled for Incorrect Lens Database Value
FDA (Devices) · 2013-11-27
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28