Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
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 an FDA Class II recall involving a surgical device where the instructions for use contain unapproved reprocessing methods. No illnesses or injuries have been reported, making the hazard theoretical. Per the rubric, risk-of-harm products where injury has not been reported score as High (3).
Plain-English summary
Karl Storz Endoscopy has recalled 299 units of KARL STORZ ENDOSKOPE ureteroscopes (REF: 27011K, 8 Fr., 6° angle, 34cm) distributed nationwide in the United States.
The instructions for use (IFU) provided with these devices include reprocessing modalities that have not been reviewed and approved by the FDA for safety and efficacy.
Healthcare facilities and medical providers using these devices should verify that any reprocessing methods employed are FDA-approved. Facilities should review their reprocessing protocols and contact Karl Storz Endoscopy for guidance on approved reprocessing methods.
The recall affects all lot numbers under UDI 04048551231357.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 299
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:04048551231357
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
Same manufacturer · Karl Storz Endoscopy
See all →- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- ModerateKarl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2025-02-05
Same hazard · improper sterilization
See all →- HighKarl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighMedical endoscope recalled for unapproved sterilization instructions
FDA (Devices) · 2024-10-02
- HighCardiac central line insertion kits lack documented sterilization validation
FDA (Devices) · 2024-02-07