Olympus recalls urologic resection sheaths (Model A22043A) due to reported ceramic tip breakage. Affected units may cause injury during medical procedures.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus is recalling urologic resection sheaths with model number A22043A because ceramic tips have broken in complaints. This could lead to injury during medical procedures if the broken tip causes bleeding or tissue damage.
The ceramic tip of the sheath can break during use, potentially causing bleeding or tissue damage. This breakage may occur during medical procedures, especially if the sheath is used for urologic applications.
Medical professionals using the Olympus Resection Sheath (Model A: A22043A) for urologic procedures are most at risk. Patients undergoing these procedures with the affected sheaths could experience injury.
Check for the model number A22043A on the sheath. The product was sold with a unique device identifier (UDI) starting with 04042761021005. All lots of this model are affected.
Inspect the ceramic tip for cracks or signs of breakage before use.
Reach out to Olympus Corporation of the Americas for further guidance on handling the affected sheath.
The recall indicates reported breakage of the ceramic tip, which could cause injury during medical procedures. Use with caution.
Look for the model number A22043A and the unique device identifier (UDI) starting with 04042761021005 on the sheath.
Inspect the ceramic tip for cracks or breakage. Contact Olympus Corporation of the Americas for further guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1445-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1445-2026 from Olympus. 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.