Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
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 unapproved reprocessing instructions that create a theoretical risk of harm through improper sterilization and potential patient infection. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported injury, scoring 3 (High).
Plain-English summary
Karl Storz Endoscopy is recalling the KARL STORZ ENDOSKOPE uretero-renoscope (model 27002L, 9.5 Fr., 43 cm). The product's instructions for use contain reprocessing and sterilization modalities that have not been reviewed and approved by the FDA for safety and efficacy.
102 units of this device have been distributed nationwide in the United States. The device is marked as non-sterile and for prescription use only.
The concern is that without FDA-reviewed reprocessing instructions, the device may not be properly sterilized before clinical use, creating a potential risk to patients. Healthcare facilities using this device should contact the manufacturer for corrected reprocessing guidance.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 102
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:04048551231265
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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