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).
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.
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.
The scopes failed sterility testing during routine checks, meaning they might not be clean enough to prevent infections. This risk is specific to medical use where contamination could directly affect patient health.
Healthcare professionals using the recalled scopes for intubation procedures are most at risk. Patients undergoing these procedures could be exposed to infection if the scopes were used without proper sterility.
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.
Look for the model name 'FIVE S 3.5x65' and serial numbers REF: 091361-01 (1 unit) or 091361-06 (6 units).
The scopes failed sterility testing during routine checks, which could lead to patient infections if used without proper cleaning.
Seven units: one with serial number REF: 091361-01 and six with serial number REF: 091361-06.
The recall does not require immediate discontinuation; check the serial number to confirm if your scope is affected.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-0184-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-0184-2022 from Karl Storz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
