Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 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: Classified as High (Score 3): a risk-of-harm medical device (invasive ureteroscope) where unapproved reprocessing procedures lack FDA review and approval. Absence of reported adverse events and Class II classification preclude higher severity scoring.
Plain-English summary
Karl Storz Endoscopy is recalling 3,069 KARL STORZ ENDOSKOPE ureteroscopes (model REF: 27010K, 7 Fr., 34 cm, non-sterile, RxONLY) distributed nationwide. All lots with UDI 04048551231319 are included in the recall.
The instructions for use (IFU) that accompany these devices contain reprocessing modalities—procedures for sterilizing and preparing the device for reuse—that have not been reviewed and approved by the FDA. Using unapproved reprocessing procedures on an invasive surgical instrument may compromise device safety and sterility.
Healthcare facilities and medical professionals with these devices should discontinue use of the reprocessing procedures outlined in the current IFU. They should contact Karl Storz Endoscopy to obtain updated reprocessing instructions that have been reviewed and approved by the FDA before continuing to use these devices.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device
- Affected units
- 3,069
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:04048551231319
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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Same hazard · unapproved reprocessing
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- ModerateKarl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
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FDA (Devices) · 2025-02-05
- HighKarl Storz Ureteroscope Model 27001K Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
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