Karl Storz Pediatric Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
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: This FDA Class II recall involves unapproved reprocessing instructions for a pediatric surgical instrument. While no illnesses or injuries have been reported, improper reprocessing of surgical instruments presents significant risk of infection and cross-contamination. The score reflects potential hazard in a medical application without confirmed adverse events.
Plain-English summary
Karl Storz Endoscopy has issued a recall for 185 Pediatric Cysto-Urethroscope units (Model 27030KB) distributed nationwide in the United States. These devices are identified by reference number 27030KB and UDI 04048551232118.
The instructions for use accompanying these devices include reprocessing instructions and methods that have not been reviewed and approved by the FDA for safety and efficacy. Proper reprocessing of surgical instruments is critical to ensure that medical devices can be safely reused in clinical settings.
Healthcare facilities and providers currently using this device should immediately review the product instructions for use and contact Karl Storz Endoscopy for updated, FDA-approved reprocessing procedures. Do not use any reprocessing methods that have not been verified by the FDA. For information and corrected instructions, contact Karl Storz Endoscopy directly.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- unapproved-reprocessing
- 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: 04048551232118
Distribution
Distributed nationwide across the United States.
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