The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2897-2020·Announced 2020-09-02

Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

Karl Storz is recalling 380 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid infection.

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 infection from incompletely sterilized medical devices, 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 380 units of the Flexible Intubation Video Endoscope (Part: 11303BNX) with Instruction Manual Z20827US. The recall is being conducted to provide updated sterilization instructions. These instructions 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 necessary because 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, including nationwide in the United States and in Canada. The recall number is Z-2897-2020. The source text does not specify the exact action consumers or healthcare providers should take beyond the provision of the updated instructions.

The recalled product

Product
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - 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 — Endoscope
Hazard
Affected units
380

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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