Olympus recalls SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m endoscopes due to potential infection from inadequate sterile packaging seals. Affected units may need replacement to prevent patient infections.
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 some SNAREMASTER PLUS Hot/Cold 10m endoscopes because their sterile packaging may have poor seals, increasing infection risk during medical procedures. This is serious for patients undergoing procedures with these devices.
The sterile packaging may not seal properly, allowing contaminants to enter the device. If non-sterile equipment is used during medical procedures, patients could develop infections.
Patients using these endoscopes for polyp removal or cauterization are at risk. Medical professionals who use the device for GI tract procedures may need to check packaging integrity.
Look for the model number SD-400U-10 on the device or packaging. The product was sold with serial numbers 97V, 98V, 9XV, 9YV, 03V, 05V, 06V.
Inspect the sterile packaging for signs of poor sealing, such as gaps or leaks.
Reach out to Olympus for guidance on whether your device needs replacement due to packaging issues.
The recall is due to a small percentage of sterile packages having inadequate seals, which could lead to infections if non-sterile equipment is used during procedures.
Check for model number SD-400U-10 and serial numbers 97V, 98V, 9XV, 9YV, 03V, 05V, or 06V on the device or packaging.
No, but you should check the packaging seal and contact Olympus to determine if replacement is needed.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0991-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0991-2021 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.
