Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions
Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.
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: The recall involves a risk of infection due to incomplete sterilization of a medical device. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling 428 units of the Flexible DCI Intubation Fiberscope, Part 11302BDD2, along with the associated Instruction Manual Z18445US. The recall is being conducted to provide updated sterilization instructions to healthcare facilities.
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 across all 50 U.S. states, the District of Columbia, and Canada. Healthcare facilities 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 DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - 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
- 428
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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