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.
What this means for you
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
- Hazard
- unapproved-reprocessing
- inadequate-sterilization
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.
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