Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.
What this means for you
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: This is an FDA Class II recall involving a labeling issue—unapproved reprocessing procedures in the instructions for use—with no reported injuries or illnesses. It falls under the Moderate category as a minor labeling error consistent with voluntary precautionary recalls.
Plain-English summary
Karl Storz Endoscopy is recalling 180 KARL STORZ ureteroscopes (Model REF: 27002K, 9.5 Fr., 6°, 34 cm, Non-Sterile) because the instructions for use contain reprocessing modalities that have not been reviewed and approved for safety and efficacy by the FDA. Ureteroscopes are medical devices used in urological procedures.
The affected devices are identified by UDI: 04048551231227 and include all lots. The units have been distributed nationwide across the United States.
Healthcare providers and facilities using these devices should immediately stop using the affected ureteroscopes and contact Karl Storz Endoscopy. The instructions for use must be updated with FDA-reviewed and approved reprocessing procedures before the devices can be used again.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- unapproved-reprocessing
- labeling-issue
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 (1)
- All Lots/UDI:04048551231227
Distribution
Distributed nationwide across the United States.
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