Karl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
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: FDA Class II medical device recall involving unapproved reprocessing instructions for a surgical instrument. No illnesses have been reported, but improper reprocessing could result in serious infections, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Karl Storz Endoscopy is recalling 221 cysto-urethroscopes (urological endoscopes), model reference 27030KA, NON STERILE, due to unapproved reprocessing instructions. The product's Instructions For Use contain reprocessing procedures that have not been reviewed and approved by the FDA for safety and efficacy.
Reprocessing—the cleaning, disinfection, and sterilization of medical instruments between patients—is essential to prevent cross-contamination. Unapproved reprocessing instructions could result in improper sterilization, increasing the risk of patient infection.
The recalled devices were distributed nationwide to hospitals and medical facilities. All lots/units with UDI 04048551232095 are affected. Affected healthcare facilities should immediately stop using the recalled cysto-urethroscopes and contact Karl Storz Endoscopy for updated, FDA-approved reprocessing instructions before continuing use.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- improper-sterilization
- infection-risk
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: 04048551232095
Distribution
Distributed nationwide across the United States.
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