Karl Storz Endoscopy Aggressive Cutters and Resectors Recall: Sterility Risk
Karl Storz recalls specific endoscopy tools due to potential sterility compromises from inner barrier holes. Affected items include 28208BKS and 28206CBS models with listed lot numbers.
Lower-risk recall
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
Contact the company
What happened, in plain English
Karl Storz is recalling certain endoscopy tools that may have holes in their inner barrier, risking contamination. This could lead to infections if used in medical procedures without proper sterility. Read more at govinfonow.com/recall/53722-karl-storz-endoscopy-aggressive-cutters-and-resectors-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53722-karl-storz-endoscopy-aggressive-cutters-and-resectors-recall-sterility-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0526-2025
Cite this page
“Karl Storz Endoscopy Aggressive Cutters and Resectors Recall: Sterility Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53722-karl-storz-endoscopy-aggressive-cutters-and-resectors-recall-sterility-risk. Based on FDA recall #Z-0526-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0526-2025%22&limit=1).
Why it’s dangerous
The tools have holes in the inner barrier system that could compromise sterility. If the tools are not properly sterilized, they might transmit infections during medical procedures.
Who’s affected
Medical professionals using the recalled endoscopy tools are most at risk. Patients undergoing procedures with these tools could face infection if the tools are not sterile.
How to tell if you have this one
Check for model numbers 28208BKS, 28206CBS, 28205NDS, 28205FDS, 28205HES, 28205GDS, and 28208IDS with specific lot numbers listed in the recall notice.
- Brand
Karl Storz- Category
Medical device
What to do — step by step
Check Product Model
Identify the model number and lot numbers from the product labels to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, Indiana, Iowa, Kansas, Massachusetts, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these tools safe to use?
The recall indicates potential sterility issues, so they should not be used until confirmed safe by the manufacturer.
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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-0526-2025 (October 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0526-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.