Olympus recalls INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM (model NM-400L-0421) due to inadequate sterile packaging seals. Patients may get infections if non-sterile equipment is used. Contact Olympus for details.
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 poor seals. This could lead to infections if the device is used without proper sterility.
The sterile packaging may not seal properly, allowing contaminants to enter. If the device is used without proper sterility, patients could develop infections.
Endoscopists and patients using this device for digestive tract procedures. Those with the model number NM-400L-0421 are most at risk.
Check for the model number NM-400L-0421 on the device. This product was sold with endoscopes for treating esophageal and gastric varices.
Inspect the packaging for signs of poor sealing, such as leaks or missing seals.
The recall indicates a small percentage of packages have inadequate seals, so it may not be safe. Use only devices with confirmed proper seals.
Look for the model number NM-400L-0421 on the device. This product was sold with endoscopes for digestive tract procedures.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0993-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0993-2021 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.
