Olympus recalls A2642 Inner Sheath for endoscopic urological use due to reported ceramic tip breakage. Affected units include all lots with UDI 04042761004084.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus is recalling its A2642 Inner Sheath for endoscopic urological procedures because users have reported the ceramic tip breaking. This could lead to complications during medical procedures if the sheath fails unexpectedly.
The ceramic tip of the sheath can break during use, potentially causing the sheath to malfunction. This could lead to complications such as bleeding or tissue damage during endoscopic procedures if the broken tip obstructs the procedure.
Urology doctors and medical staff using the Olympus A2642 Inner Sheath for endoscopic procedures are most at risk. Patients undergoing these procedures may also be affected if the sheath breaks during treatment.
Check for the model number A2642 on the sheath. The unique device identifier (UDI) is 04042761004084. All lots of this product are affected.
Inspect the ceramic tip for cracks or signs of damage before use.
Reach out to Olympus Corporation of the Americas for guidance on next steps.
The recall indicates reported breakage issues, so it's not recommended for use until the manufacturer provides guidance.
Look for the model number A2642 and the unique device identifier (UDI) 04042761004084 on the sheath.
Contact Olympus Corporation of the Americas for instructions on next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1456-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1456-2026 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.