Karl Storz recalls cysto-urethroscopes with model 27030KA due to unapproved reprocessing methods that could pose safety risks. Affected units include specific lots and UDI numbers.
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Karl Storz is recalling cysto-urethroscopes with model number 2703:0KA that have unapproved reprocessing instructions. This could lead to safety issues if the device is reprocessed without FDA approval.
The reprocessing instructions for these cysto-urethroscopes have not been reviewed by the FDA for safety and efficacy. This means the device could be unsafe if reprocessed without proper approval.
Healthcare professionals using the cysto-urethroscope for medical procedures are most at risk. Patients using these devices may also be affected if the reprocessing is done incorrectly.
Check for the model number 27030KA on the device. Affected units have specific lot numbers and UDI: 04048551232095.
Look for the model number 27030KA on the cysto-urethroscope.
Confirm the lot number matches the affected units listed: 04048551232095.
The device is safe for use as intended, but reprocessing without FDA-approved methods could pose risks.
Check the model number and lot number to see if it's affected. If it is, contact Karl Storz for guidance.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1052-2025 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1052-2025 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.
