Z-2897-2020Class II

Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US -

Name: Z-2897-2020 Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US -
Creator: Karl Storz Endoscopy
Published: 2020-07-27
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2020-07-27 / Open, Classified / root cause: design

FDA source

Karl Storz Endoscopy began a recall of Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and... on 2020-07-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2897-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-27
Posted: 2020-08-27
Recalling firm: Karl Storz Endoscopy-America, Inc.
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.
Product code: CAL Laryngoscope, Non-Rigid
Reason for recall: 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 tag: design
FDA 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 in commerce: 380
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.
Product codes and lots: Instruction Manual Version: 01/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2897-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2890-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2891-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2892-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2893-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2894-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2895-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2896-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27
Z-2897-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-27

Product code CAL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)