Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates
Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.
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 involves a risk-of-harm product (infection from incomplete sterilization) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Karl Storz Endoscopy is recalling 1,246 units of the Flexible Intubation Fiberscope (Part: 11301BN1) with Instruction Manual Z18441US. The recall is being conducted to provide updated sterilization instructions for these reusable medical devices. The devices are intended for the examination and visualization of a patient's upper airway and for aiding the placement of an endotracheal tube.
The updated instructions are necessary to ensure that a specific sterilization tray is not used and that ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. The source text notes that incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
The affected products were distributed worldwide, including nationwide distribution in the United States and in Canada. The recall covers instruction manual version 08/2018. Healthcare facilities and users should stop using the affected devices and refer to the updated sterilization instructions provided by the manufacturer to ensure proper sterilization protocols are followed.
The recalled product
- Product
- Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Endoscopy
- Affected units
- 1,246
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)
- Instruction Manual Version: 08/2018
Distribution
Part of a larger recall action
This product is one of 8 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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