Class II — Carl Zeiss Meditec, Inc.
| Recalling firm | Carl Zeiss Meditec AG (Jena) |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Product | INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. |
| Quantity | 36 total, all lots |
| Distribution | Nationwide Distribution including IL and MD |
| Initiated | 2012-10-25 |
| Classified | 2012-11-20 |
| Terminated | 2012-11-20 |
| Recall number | Z-0406-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carl Zeiss Meditec, Inc. (Z-0406-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63596/
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