Karl Storz Ureteroscope Model 27001K Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
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 Class II recall involving unapproved reprocessing instructions for a surgical device. Proper reprocessing is critical for device safety. While no illnesses or injuries have been reported, the product poses a risk of harm if improper reprocessing procedures are followed, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling the KARL STORZ Ureteroscope, Model 27001K (9.5 Fr., 6°, 34 cm), a non-sterile surgical device. A total of 185 units have been distributed nationwide.
The recall is due to the Instructions for Use containing reprocessing modalities that have not been reviewed or approved by the FDA for safety and efficacy. Proper reprocessing is essential to ensure the device is safe and effective for use.
Healthcare facilities and medical professionals who have received this device should contact Karl Storz Endoscopy for corrected Instructions for Use or further guidance regarding their affected units.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- unapproved-reprocessing
- infection-risk
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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