Olympus recalls certain endoscopic injectors due to potential inadequate sterile packaging, which could lead to infections if used improperly. Affected models include NM-400U-0623 with specific serial numbers.
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 a specific endoscopic injector model because some sterile packages have poor seals. This could allow infections if the device is used without proper sterility.
The sterile packaging may not seal properly, allowing contaminants to enter the device. If the device is not sterile, it could cause infections during medical procedures.
Healthcare professionals using endoscopes for digestive tract procedures may be affected. Patients receiving treatment with this device are at risk if the seal is compromised.
Check for model number NM-400U-0623 with serial numbers listed in the product description (01K through 9ZK and 05V through 09V).
Inspect the sterile packaging for signs of inadequate sealing, such as leaks or improper closure.
The recall indicates a small percentage of packages have inadequate seals, so it may not be sterile. Do not use if the seal appears compromised.
Check for model number NM-400U-0623 with serial numbers from the list provided in the product description (01K through 9ZK and 05V through 09V).
Inspect the packaging for proper sealing. If the seal is inadequate, do not use the device and contact Olympus for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1020-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1020-2021 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.
