Surgical Optical Scissors Recalled Due to Inadequate Reprocessing Evidence
Karl Storz optical scissors (REF 115400S) are being recalled due to inadequate validation evidence for reprocessing procedures. The 27 affected units were distributed nationwide; users should contact the manufacturer for guidance.
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 is an FDA Class II recall of a surgical instrument with inadequate reprocessing validation evidence. No hospitalizations, illnesses, or injuries have been reported. The hazard represents a risk-of-harm scenario (potential infection from improper reprocessing) where actual injury has not yet occurred, warranting a High severity per the FDA rubric.
Plain-English summary
Karl Storz SE & CO. KG optical scissors (model REF 115400S) are subject to a Class II recall. A total of 27 units were distributed across the United States.
The recall is due to inadequate validation evidence demonstrating that these optical scissors can be safely reprocessed for reuse. Proper reprocessing validation is critical for surgical instruments to ensure they function correctly and safely during procedures.
Affected facilities in the following states should verify whether they received affected units and contact Karl Storz Endoscopy for guidance: AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO, ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, and WV. No illnesses or injuries have been reported. Users should follow the manufacturer's recommendations regarding safe use and reprocessing of affected units.
The recalled product
- Product
- Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- reprocessing-failure
- 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)
- UDI: 04048551259788/ All Lots
Distribution
Distributed nationwide across the United States.
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