Lower risk Medical device recall · FDA · Published September 10, 2021

Karl Storz Endoscopy Scopes Risk Patient Infection - Recall

Karl Storz recalls 7 flexible intubation video scopes due to potential infection risk from inadequate sterility. Affected models include REF: 091361-01 (1 unit) and 091361-06 (6 units).

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0184-2022Medical device Karl Storz ›

Lower-risk recall

During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.

Take action

Contact the company

Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017

✎ GovInfoNow plain-language explainer

Karl Storz is recalling 7 flexible intubation video scopes because they may not have met sterility standards during testing, risking patient infections. This affects medical devices used in procedures like intubation. Read more at govinfonow.com/recall/61803-karl-storz-endoscopy-scopes-risk-patient-infection-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/61803-karl-storz-endoscopy-scopes-risk-patient-infection-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0184-2022

Cite this page

“Karl Storz Endoscopy Scopes Risk Patient Infection - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61803-karl-storz-endoscopy-scopes-risk-patient-infection-recall. Based on FDA recall #Z-0184-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0184-2022%22&limit=1).

Karl Storz Endoscopy is recalling five FIVE S 3.5x65 Flexible Intubation Videoscopes because they may not achieve required sterility, posing an infection risk, the FDA said on Sept. 10, 2021.

How to tell if you have it

Brand: Karl Storz
Product: FIVE S 3.5x65, Flexible Intubation Videoscope
REF: 091361-01 (1 Unit)
REF: 091361-06 (6 Units)
Lot codes: All LOTs with remaining shelf life

The hazard

Context

GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since Oct. 10, 2017. Other recent recalls include a Karl Storz HOPKINS Telescope recall regarding incorrect eyepiece packaging labels (Aug. 12, 2026) and Karl Storz Flexible Hystero-Fiberscope Kits involving expired sterility seal risks (May 21, 2026). Other recent recalls of similar products include Medline Convenience Kits recalls regarding calibration issues affecting sterility (Jan. 7, 2026) and an Argon Medical Devices One-Piece Introducer Tray recall citing sterility risk (June 1, 2026).

How to tell if you have this one

Check for the model name 'FIVE S 3.5x65' and serial numbers REF: 091361-01 (1 unit) or 091361-06 (6 units). The recall covers all remaining shelf life units.

Brand
Karl Storz
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Scope Serial Number
Look for the model name 'FIVE S 3.5x65' and serial numbers REF: 091361-01 (1 unit) or 091361-06 (6 units).

Where it went and when

Where it was distributed

Distributed in 39 states and D.C., and outside the U.S.

FDA distribution: “US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT. OUS: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 10, 2021Firm started the recall
Oct 29, 2021FDA classified it Class II
Nov 10, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these scopes?

The recall does not require immediate discontinuation; check the serial number to confirm if your scope is affected.

Similar recalls

Latest medical device recalls

Keep exploring

More Karl Storz recalls

Link to this recall

<a href="https://govinfonow.com/recall/61803-karl-storz-endoscopy-scopes-risk-patient-infection-recall">Karl Storz Endoscopy Scopes Risk Patient Infection - Recall (GovInfoNow)</a>

Where this comes from

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-0184-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0184-2022 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.