Olympus recalls INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM (model NM-400L-0625) due to potential inadequate sterile package seals, which could lead to patient infections if non-sterile equipment is used.
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. This could lead to infections if the device is used without proper sterility.
The sterile packages may have partial heat seals, meaning they are not properly sealed. If the device is not sterile, it could cause infections during medical procedures.
Patients using this endoscopic injection device for treating esophageal and gastric varices or digestive tract issues. Medical professionals who use the device are most at risk.
Check for model number NM-400L-0625 on the product. The device was sold in specific batches labeled 01K, 04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the sterile package for adequate sealing; if the seal appears damaged or incomplete, do not use the device.
The device may have inadequate sterile package seals, so it is not safe to use without checking the seal first.
Check the package seal; if it appears damaged, do not use it. Contact Olympus for further guidance.
Look for model number NM-400L-0625 and batch codes 01K, 04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1015-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1015-2021 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.
