The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2896-2020·Announced 2020-09-02

Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

Karl Storz Endoscopy is recalling 2,668 flexible intubation video endoscopes to provide updated sterilization instructions and prevent 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 introducing infectious agents into patient airways, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Karl Storz Endoscopy is recalling 2,668 units of the Flexible Intubation Video Endoscope (Part: 11302BDX) with Instruction Manual Z18443US. The recall is being conducted to provide updated sterilization instructions 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 hazard associated with this recall is that incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection. The product is intended to be used for examination and visualization of a patient's upper airway and for aiding placement of an endotracheal tube.

The affected units were distributed worldwide and nationwide in the United States, including in all 50 states, the District of Columbia, and Canada. The instruction manual version involved is 01/2020. Users should follow the updated sterilization instructions provided by the manufacturer to ensure proper sterilization of the devices.

The recalled product

Product
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - 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
2,668

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: 01/2020

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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