Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
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 Class II recall involves unapproved reprocessing procedures for an invasive medical device. While no adverse events are reported, improper reprocessing creates a defined risk of patient harm.
Plain-English summary
Karl Storz Endoscopy is recalling 65 Uretero-Renoscope units (model REF 27000L, 7 Fr., 6°, 43 cm) distributed nationwide in the United States.
The Instructions for Use (IFU) for these devices contain reprocessing modalities that have not been reviewed and/or approved by the FDA for safety and efficacy.
Healthcare facilities currently using these devices should contact Karl Storz Endoscopy for clarification on proper reprocessing procedures. The FDA is monitoring this recall. Affected units are identified by UDI 04048551311271.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 65
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: 04048551311271
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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