Karl Storz Flexible Bronchoscope Recall: Inadequate Disinfection Risk
Karl Storz recalls flexible bronchoscopes from 2018-2019 with potential inadequate disinfection, risking infection. Affected units have specific serial numbers and UDI codes.
Lower-risk recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Contact the company
What happened, in plain English
Karl Storz is recalling certain flexible bronchoscopes made from January 2018 onward due to a risk that disinfection may not reduce microorganisms to the expected level. This could lead to infections if the device is used without proper cleaning. Read more at govinfonow.com/recall/60843-karl-storz-flexible-bronchoscope-recall-inadequate-disinfection-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60843-karl-storz-flexible-bronchoscope-recall-inadequate-disinfection-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1055-2022
Cite this page
“Karl Storz Flexible Bronchoscope Recall: Inadequate Disinfection Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60843-karl-storz-flexible-bronchoscope-recall-inadequate-disinfection-risk. Based on FDA recall #Z-1055-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1055-2022%22&limit=1).
Why it’s dangerous
The bronchoscope may not achieve the required six-log reduction in microorganisms after disinfection. This means harmful bacteria and viruses could remain on the device, potentially causing infections during medical procedures.
Who’s affected
Healthcare professionals using the recalled bronchoscopes are most at risk. Patients undergoing procedures with these devices may also be affected if the disinfection process fails.
How to tell if you have this one
Check for the model numbers 11005BC1 or 11005BCK1 with UDI code 04048551225738. These units were manufactured and distributed starting in January 2018.
- Brand
Karl Storz- Category
Medical device
All 2 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
U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
| Recall number | Product, codes & lots |
|---|---|
| Z-1054-2022 | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018); 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) UDI Code: 0408551225608 All Serial Numbers manufactured/distributed since January 2018 |
| Z-1055-2022 | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019); 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018 |
What to do — step by step
Check Serial Numbers
Look for the model numbers 11005BC1 or 11005BCK1 with UDI code 04048551225738 on the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 14 states.
FDA distribution: “U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New Jersey, North Carolina, Oklahoma, South Carolina, Texas, Washington.
Recall timeline
FDA published this recall 47 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.
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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-1055-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1055-2022 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.