Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz Endoscopy is recalling 5 nephroscopes because their instructions for use list reprocessing methods not reviewed or approved by the FDA.
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: The recall involves a medical device with unapproved reprocessing instructions, creating a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Karl Storz Endoscopy is recalling five units of the Nephroscope for MIP M (REF: 27830KA). The recall was initiated because the Instructions for Use (IFU) for these medical devices contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
The affected units were distributed nationwide across the United States, including all 50 states, the District of Columbia, Puerto Rico, and Guam. The specific UDI for the recalled units is (01)04048551234099.
Healthcare providers and facilities should stop using the affected nephroscopes and contact Karl Storz Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Hazard
- 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: (01)04048551234099
Distribution
Part of a larger recall action
This product is one of 8 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.
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