Karl Storz Flexible Pediatric Neuroscopes Recalled Due to Sterilization Manual Error
Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
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: The recall is classified as FDA Class II. The hazard involves a potential failure to guarantee sterility, which is a significant risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Karl Storz Endoscopy is recalling 73 units of the NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope. The recall was initiated after a complaint investigation revealed an error in the instruction manual included with some of the scopes.
The specific error involves incorrect Quick Connector Kits (QCK) and tray information for the STERIS System 1E (SS1E) sterilization method. If a user relies on the manual's QCK information while using the SS1E method to sterilize these scopes, the sterility of the reprocessed scope cannot be guaranteed.
The affected devices were distributed in the United States (AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV) and Canada. Users should stop using the affected scopes and contact Karl Storz Endoscopy for instructions on how to proceed.
The recalled product
- Product
- Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Affected units
- 73
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
Distribution
Part of a larger recall action
This product is one of 3 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.
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