Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM models due to inadequate sterile packaging seals that could lead to 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 specific endoscopic injectors because some sterile packages have poor seals, which could cause infections if non-sterile equipment is used during medical procedures.
The sterile packaging may not seal properly, allowing contaminants to enter the product. If non-sterile equipment is used during medical procedures, patients could develop infections.
Patients using these injectors for endoscopic procedures may be at risk of infection if the package seal is inadequate. Medical professionals using the product are most affected.
Check for model number NM-400L-0425 on the product. These injectors were sold with endoscopes for treating esophageal and gastric varices or digestive tract injections.
Inspect the sterile packaging for proper sealing; if the seal appears damaged or incomplete, do not use the product.
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 medical procedures.
Look for model number NM-400L-0425 on the product, which was sold with endoscopes for treating esophageal and gastric varices or digestive tract injections.
Inspect the sterile packaging for proper sealing; if the seal appears damaged or incomplete, do not use the product.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1013-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1013-2021 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.