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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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