The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2894-2020·Announced 2020-09-02

Karl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions

Karl Storz is recalling 463 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.

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 (infection) from a medical device where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

Karl Storz Endoscopy is recalling 463 units of the Flexible DCI Intubation Fiberscope (Part: 11301BND1) to provide updated sterilization instructions. The recall is intended 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 recall is being conducted because incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection. The affected products are intended for the examination and visualization of a patient's upper airway and for aiding the placement of an endotracheal tube.

The recall covers units distributed worldwide and nationwide in the U.S., including in 49 states, the District of Columbia, and Canada. The specific instruction manual version involved is 08/2018. Users should refer to the updated instructions provided by the manufacturer to ensure proper sterilization protocols are followed.

The recalled product

Product
Flexible DCI Intubation Fiberscope, Part: 11301BND1, 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
Hazard
Affected units
463

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

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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.

See all 8 products in this recall →

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