Karl Storz Flexible Neuroscopes Recalled Due to Sterilization Manual Error
Karl Storz is recalling 42 flexible 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 risk of harm (compromised sterility) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Karl Storz Endoscopy is recalling 42 units of the Model # 11161C2 Flexible 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 Kit (QCK) and tray information for the STERIS System 1E (SS1E) sterilization method. If a user relies on this manual to sterilize the affected scopes using the SS1E method, 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 for sterilization via the SS1E method until corrected instructions are provided.
The recalled product
- Product
- Karl Storz, Model # 11161C2, Flexible Neuroscope
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Affected units
- 42
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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