Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.
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: This is a medical device with risk-of-harm potential due to unapproved reprocessing instructions. The source text contains no reported injuries or illnesses, meeting the rubric criterion for a high-risk product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling the MICHEL Uretero-Renoscope (REF 27003L, 9.5 Fr., 43 cm). The device has been distributed across the United States. The recall affects 4 units.
The recall is issued because the device's Instructions for Use contain reprocessing modalities that have not been reviewed and approved for safety and efficacy by the FDA.
Users should contact Karl Storz Endoscopy to obtain FDA-approved reprocessing instructions for the device.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 4
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: 04048551231296
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Karl Storz Endoscopy 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 14 products in this recall →Related recalls
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