Lower risk Medical device recall · FDA · Published May 21, 2026

Karl Storz Flexible Hystero-Fiberscope Kits: Expired Sterility Seal Risk

Karl Storz recalls flexible hystero-fiberscope kits with expired single-use endoscopic seals for gynecology procedures, which could compromise sterility during medical use.

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

🇺🇸 FDA recall #Z-2794-2026Medical device Karl Storz ›

Lower-risk recall

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

✎ GovInfoNow plain-language explainer

Karl Storz is recalling flexible hystero-fiberscope kits that contain expired single-use endoscopic seals. This could lead to compromised sterility during medical procedures, posing a risk of infection. Read more at govinfonow.com/recall/127893-karl-storz-flexible-hystero-fiberscope-kits-expired-sterility-seal-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/127893-karl-storz-flexible-hystero-fiberscope-kits-expired-sterility-seal-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2794-2026

Cite this page

“Karl Storz Flexible Hystero-Fiberscope Kits: Expired Sterility Seal Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127893-karl-storz-flexible-hystero-fiberscope-kits-expired-sterility-seal-risk. Based on FDA recall #Z-2794-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2794-2026%22&limit=1).

The FDA announced on May 21, 2026, that Karl Storz Endoscopy is recalling Flexible Hystero-Fiberscope Kits REF: 11264BBU1 and 11264BBUK1 because they may contain an expired single-use endoscopic seal. This expiration could impact the assurance of sterility for the devices.

How to tell if you have it

Brand: Karl Storz
Product: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1
Kit UDI-DI: 04048551226087
Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785
Seal REF: 26153EAU/1 with expiration date January 23, 2023
Distribution: US Nationwide in FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT

The hazard

The flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single-use endoscopic seal for gynecology use. This condition could impact the assurance of sterility.

Context

GovInfoNow's records show Karl Storz Endoscopy has had 24 other recalls on record since October 10, 2017. Other recent recalls of similar products include HOPKINS Telescope 30¿, 4mm REF 10005BA (August 12, 2026), Karl Storz Cysto-Urethroscope (December 19, 2024), and Karl Storz Endoscopy Optical Biopsy Forceps (December 19, 2024). Other recent recalls of similar products include Medline Convenience Kits (January 7, 2026) and Boston Scientific EndoVive Safety PEG Kit (February 10, 2026).

How to tell if you have this one

Check for kit serial numbers listed in the recall: 2274269, 2273282, 2276217, and other numbers provided. The expired seal has a January 23, 2023 expiration date.

Brand
Karl Storz
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Serial Numbers
Look for serial numbers on the kit that match the list provided in the recall: 2274269, 2273282, 2276217, and others.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 15 states.

FDA distribution: “US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Vermont, Virginia, Wisconsin.

Recall timeline

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

May 21, 2026Firm started the recall
Jul 23, 2026FDA classified it Class II
Jul 29, 2026Published 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

Is there a risk of serious injury?

The recall addresses potential infection risk from compromised sterility, not direct injury risks.

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Link to this recall

<a href="https://govinfonow.com/recall/127893-karl-storz-flexible-hystero-fiberscope-kits-expired-sterility-seal-risk">Karl Storz Flexible Hystero-Fiberscope Kits: Expired Sterility Seal Risk (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-2794-2026 (May 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2794-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.