Karl Storz Endoscopy: 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.

Recall number

Z-2896-2020

Recalling firm

Karl Storz Endoscopy

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.

Status

Open, Classified

Initiated

2020-07-27

Posted

not on file

Terminated

not on file

Reason

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

Root cause

Device Design

Action

On 07/27/2020, Urgent Medical Device Correction notices were mailed to customers. Customers were informed that this labeling change corrects the instructions for sterilization of the impacted endoscopes using STERRAD or EtO modalities. Do not use any impacted endoscope until you have confirmed that it has been appropriately sterilized in accordance with the instructions in the correction notice or via another method specified in instructions for use with updated sterilization information. When sterilizing one of the impacted flexible intubation endoscopes with the STERRAD NX Advanced Cycle or STERRAD 100NX Flex Cycle, one of the sterilization trays or containers specified below should be used: Model/Use Tray or Container: 11301AA1, 11301BND1/ASP Aptimax Tray (13837); 11301BNX, 11302BDX, 11303BNX/ASP Aptimax Tray (13837), or KARL STORZ SteriTite Container (KSZ-39406AS); 11301BN1, 11302BD2, 11302BDD2/ ASP Aptimax Tray (13837), or KARL STORZ SteriTite Container (KSZ-39402AS) The recommendation for ethylene oxide sterilization is being removed from the labeling of affected endoscopes. Customers are asked to do the following: -Examine your inventory. -Complete, sign, and return the Acknowledgement Response Form. -If impacted endoscopes are in inventory, ensure all relevant personnel in your organization are made aware of the information in this notice. -If you previously purchased a KARL STORZ plastic (Udel) sterilization trays are being used to sterilize impacted endoscopes, you may be entitled to a refund or credit. To inquire about refund/credit or for ordering assistance for SteriTite container for STERRAD sterilization, call Customer Support: 800-421-0837, press 1. -Instruction manuals are being updated for the impacted endoscopes. -Updated documents can be accessed electronically on or after August 7th at https://spwebspace.karlstorz.com/sites/ISRU. Correction Inquiries: Contact Medical Affairs Department at 800-649-8852 or medicalaffairs@karlsto

Quantity

2668

Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of CA, NY, PA, AZ, OH, NJ, FL, NC, IL, SC, MA, IA, ND, WI, UT, AR, GA, WA, KY, CO, TX, TN, AL, LA, NE, WV, MO, MN, VA, MT, CT, MI, IN, NM, NV, ME, VT, NH, WY, DC, DE, OR, OK, MD, ID, AK, MS, KS, HI, RI, SD and the country of Canada.

Lot, serial or model codes

Instruction Manual Version: 01/2020

510(k) numbers

not on file

PMA numbers

not on file

Product code

CAL

Firm FEI

3007475226

Firm city

El Segundo

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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