Erbe Medical recalls CleverCap hybrid tubing sets for Olympus and Fujifilm scopes due to potential water aspiration leading to pneumonia or respiratory failure. Affected units include specific model numbers and production lots.
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Erbe Medical is recalling CleverCap hybrid tubing sets for Olympus and Fujifilm endoscopes because a design flaw may cause water to flow into the patient's lungs during use, potentially leading to serious respiratory issues. This recall affects specific model numbers and production lots.
The tubing connector design may allow water to flow from the endoscope tip into the patient's lungs if the connector is not properly secured. This can lead to water aspiration, which may progress to pneumonia, acute respiratory distress syndrome, or respiratory failure.
Medical professionals using endoscopes with these specific CleverCap sets are at risk. Patients undergoing procedures with the recalled equipment could experience water aspiration.
Check for model numbers 20325-201 or 20325-203 on the packaging. The affected units include specific production lots listed in the recall notice.
Identify the model number and production lot from the packaging or label.
Reach out to Erbe Medical for guidance on next steps if you have the recalled product.
The tubing connector design may allow water to flow into the patient's lungs during use, potentially leading to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Endoscopic procedures using Olympus or Fujifilm scopes with the recalled CleverCap sets.
Look for model numbers 20325-201 or 20325-203 on the packaging, and check the production lots listed in the recall notice.
We’ve drafted a message you can send Erbe Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2063-2026 — Erbe Medical Erbe Medical Hello, I own a Erbe Medical that is covered by recall Z-2063-2026 from Erbe Medical. 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.
