Olympus recalls INJECTOR FORCEMAX LOWER 25G 6MM (model NM-400U-0625) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used during endoscopic procedures.
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 injection device because some sterile packages have inadequate seals, which could lead to infections if the device is used without proper sterility. This is a serious risk for patients undergoing endoscopic procedures.
The device's sterile packaging may have partial heat seals, meaning the seal could be broken during storage or handling. If the packaging is compromised, the device might not be sterile, increasing the risk of infection during medical procedures.
Healthcare professionals using the INJECTOR FORCEMAX LOWER 25G 6MM device for endoscopic procedures are most at risk. Patients receiving these procedures could be affected if the device is not properly sterilized.
Check for the model number NM-400U-0625 on the device. The product was sold with specific endoscope codes (01K through 9ZK and 05V through 09V).
Inspect the packaging for signs of partial heat sealing, which could indicate a compromised seal.
The recall indicates a small percentage of packages have inadequate seals, so it may not be sterile. Use only devices with confirmed proper seals.
Look for the model number NM-400U-0625 and endoscope codes listed in the product description (01K through 9ZK and 05V through 09V).
The recall does not specify a remedy, so contact Olympus directly for guidance on safe handling or disposal.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1007-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1007-2021 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.
