Lower riskMedical device recall · FDA · Published July 27, 2020
Karl Storz Flexible Intubation Fiberscope Recall: Infection Risk from Improper
Karl Storz recalls flexible intubation fiberscopes with part number 11301BN1 due to infection risk from improper sterilization. Updated instructions prevent using certain trays and ethylene oxide gas.
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.
Take action
Contact the company
📍Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017
“Karl Storz Flexible Intubation Fiberscope Recall: Infection Risk from Improper.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64616-karl-storz-flexible-intubation-fiberscope-recall-infection-risk-from-improper. Based on FDA recall #Z-2892-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2892-2020%22&limit=1).
The FDA announced on July 27, 2020, that Karl Storz Endoscopy is recalling Flexible Intubation Fiberscopes due to incomplete sterilization risks. The agency said the devices might introduce infectious agents into patient airways if not properly cleaned.
How to tell if you have it
Brand: Karl Storz
Product: Flexible Intubation Fiberscope
Part Number: 11301BN1
Instruction Manual: Z18441US (Version 08/2018)
Quantity: 1,246 units
The hazard
The recall addresses the risk of incomplete sterilization because specific trays are prohibited and ethylene oxide sterilization must never be used on these reusable endoscopes. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
Context
GovInfoNow's records show Karl Storz Endoscopy has had 24 other recalls since October 10, 2017. Recent brand recalls include a HOPPIN Telescope recall on August 12, 2026, and a Flexible Hystero-Fiberscope Kits recall on May 21, 2026. Other recent recalls of similar products include Medline Surgical Drapes Recall (January 7, 2026), Bayer Stellant FLEX Syringe Kit Recall (July 31, 2026), and Medline Convenience Kits Recall (January 7, 2026).
How to tell if you have this one
Check for part number 11301BN1 on the fiberscope or instruction manual version 08/2018. These devices are used for airway exams and endotracheal tube placement in medical settings.
Brand
Karl Storz
Category
Medical device
FDA recall event · 8 products
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-2890-2020
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - 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.; Instruction Manual Version: 08/2018
91
Z-2891-2020
Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - 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.; Instruction Manual Version: 01/2020
2083
Z-2892-2020
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - 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.; Instruction Manual Version: 08/2018
1246
Z-2893-2020
Flexible Intubation Fiberscope, Part: 11302BD2, 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.; Instruction Manual Version: 08/2018
650
Z-2894-2020
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.; Instruction Manual Version: 08/2018
463
Z-2895-2020
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, 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.; Instruction Manual Version: 08/2018
428
Z-2896-2020
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.; Instruction Manual Version: 01/2020
2668
Z-2897-2020
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.; Instruction Manual Version: 01/2020
380
Based on the official FDA remedy
What to do — step by step
Check Sterilization Instructions
Review the instruction manual for updated sterilization guidelines to avoid using specific trays or ethylene oxide gas on longer fiberscopes.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2892-2020 (July 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2892-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.