Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.
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 a Class II medical device recall involving a surgical endoscope with Instructions for Use containing reprocessing procedures that lack FDA review or approval. While no illnesses or injuries have been reported, improper reprocessing and sterilization of surgical instruments present a risk of harm to patients. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is a surgical endoscope used in urological procedures. The FDA has issued a recall affecting 5 units that were distributed nationwide in the United States.
The product is being recalled because the Instructions for Use (IFUs) contain reprocessing modalities that have not been reviewed and approved by the FDA. Proper reprocessing and sterilization of surgical instruments are critical to ensure patient safety and product efficacy.
Users of this product should be aware that the reprocessing procedures outlined in the current IFUs have not been FDA-reviewed or approved for safety and efficacy. Contact Karl Storz Endoscopy for updated Instructions for Use or guidance on appropriate reprocessing procedures.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 5
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: 04048551231371
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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