Olympus recalls certain INJECTOR FORCEMAX LOWER 25G 2.5MM endoscopic needles due to inadequate sterile packaging seals, which may cause infections if used improperly.
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 needle model because some sterile packages have poor seals that could lead to infections. This is serious because medical devices must be sterile to prevent patient infections.
The sterile packages have partial heat seals that may not close properly. If the seal fails, the needle could become non-sterile, increasing the risk of infections during medical procedures.
Patients using endoscopic procedures with this specific needle model are affected. Healthcare providers who use the product for treating esophageal and gastric varices or digestive tract injections are most at risk.
Check for the model number NM-400U-0425 on the product. The product was sold with batch codes 01K through 9ZK and 05V through 0XV.
Inspect the sterile packaging for a partial heat seal that may not close properly.
Reach out to Olympus for guidance on whether the product is safe to use.
The recall indicates some packages have inadequate seals, so it may not be sterile. Contact Olympus for specific guidance.
Check the package seal and contact Olympus for advice on whether to use it safely.
Look for model number NM-400U-0425 with batch codes 01K through 9ZK and 05V through 0XV.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1003-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1003-2021 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.
