Zeiss Intrabeam Spherical Applicator failed manufacturing specifications
Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm units because they failed to meet manufacturing specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is manufacturing non-compliance without evidence of resulting harm. This matches FDA Class II without reported adverse events, which typically rates 2 (Moderate).
Plain-English summary
Zeiss Intrabeam Spherical Applicator 1.5 cm (Model REF: 304534-6000-557) units manufactured by Carl Zeiss Meditec AG are being recalled because they failed to meet manufacturing specifications. This is a radiation therapy accessory device.
A total of 13 units have been distributed worldwide. In the United States, the affected units were distributed in Florida and Puerto Rico. International distribution includes China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
The recalled units are identified by UDI (01)04049539101563, Batch number A0002. In the US, serial numbers affected are A63141 and A63086. Outside the US, the affected serial numbers are A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, and A6313.
Patients or healthcare providers in possession of affected units should contact Carl Zeiss Meditec AG for instructions on the appropriate course of action.
The recalled product
- Product
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Manufacturer
- Carl Zeiss Meditec AG
- Affected units
- 13
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 (12)
- UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141
- A63086 OUS (Outside the US) - A63085
- A63096
- A63101
- A63102
- A63105
- A63107
- A63108
- A63109
- A63110
- A63112
- A6313
Distribution
Related recalls
Same manufacturer · Carl Zeiss Meditec AG
See all →- HighZEISS miLOOP Lens Fragmentation Device Recalled for Slider Friction Issue
FDA (Devices) · 2022-05-04
- HighCarl Zeiss Meditec Recalls IOLMaster 700 Devices Due to Patient Data Mismatch
FDA (Devices) · 2021-02-24
- SevereCarl Zeiss Meditec VISUREF 150 Recalled for Electrical Shock Risk
FDA (Devices) · 2020-12-23
- HighCarl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk
FDA (Devices) · 2020-12-23
- HighCarl Zeiss IOLMaster 700 Recalled for Incorrect Calibration Settings
FDA (Devices) · 2018-10-24
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighCarl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect
FDA (Devices) · 2012-11-28
- HighCarl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets
FDA (Devices) · 2012-11-28
- HighINTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect
FDA (Devices) · 2012-11-28
- ModerateCarl Zeiss INTRABEAM PRS 500 Radiation Therapy Devices Recalled for Calibration Error
FDA (Devices) · 2017-10-11
- HighICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
FDA (Devices) · 2021-02-17
- SevereExtended Tip Applicator 15 CM recalled for endotoxin and sterility issues
FDA (Devices) · 2025-07-02