Olympus recalls INJECTOR FORCEMAX LOWER 23G 5MM (model NM-400U-0523) due to potential infection from non-sterile packaging. Affected units sold in specific batches.
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 used. This affects medical professionals using the device for digestive tract procedures.
The sterile packaging may have partial heat seals, allowing contaminants to enter. If the device is used without proper sterility, patients could get infections during procedures.
Medical professionals who use this device for endoscopic procedures are most at risk. Patients using the device could develop infections if non-sterile equipment is used.
Check for the model number NM-400U-0523 on the device. Affected units were sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the packaging for partial heat seals that may allow contamination.
The device may have inadequate packaging seals, which could lead to infections if non-sterile. Do not use if you suspect a seal issue.
Look for the model number NM-400U-0523 on the device. Affected units were sold in specific batches labeled 01K through 9ZK and 05V through 09V.
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-1004-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1004-2021 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.
