Olympus recalls SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m endoscopes due to potential packaging seal failures that could lead to infections if non-sterile equipment is used. Affected units sold in specific regions and models.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Olympus is recalling its SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m endoscopes because a small percentage have inadequate sterile packaging seals. This could lead to infections if non-sterile equipment is used during procedures.
The sterile packaging for these endoscopes may not seal properly, allowing contaminants to enter. If non-sterile equipment is used during procedures, patients could develop infections.
Healthcare professionals using the SD-400U-15 model for endoscopic procedures in the U.S. are most at risk if the packaging seal fails, potentially leading to infections.
Check for the model number SD-400U-15 on the product label. The device is used with endoscopes for removing polyps and tissue from the GI tract. Affected units were sold in specific regions and versions (97V, 98V, 03V, 04V, 06V).
Inspect the sterile packaging for proper sealing; if the seal appears damaged or incomplete, do not use the device.
The recall indicates a small percentage of units have inadequate packaging seals, which could lead to infections if non-sterile equipment is used. Not all units are affected.
Look for the model number SD-400U-15 on the product label. Affected units were sold in specific regions and versions (97V, 98V, 03V, 04V, 06V).
Inspect the packaging seal; if it appears damaged or incomplete, do not use the device. Contact Olympus 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-0992-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0992-2021 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.
