Olympus recalls certain INJECTOR FORCEMAX Lower 23G 4MM endoscopic needles due to inadequate sterile packaging seals, which 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 injection needles because some sterile packages have poor seals. This could let bacteria enter the body during procedures, causing infections.
The sterile packaging may not seal properly, allowing bacteria to enter the needle. If the needle is used without a proper seal, it could cause infections during medical procedures.
Healthcare professionals using the recalled model numbers for endoscopic procedures are affected. Patients receiving these injections may be at risk if the needles are not sterile.
Check for model number NM-400U-0423 on the packaging. The product was sold in specific series: 01K through 0XK, 98K through 9ZK, and 05V through 09V.
Inspect the packaging for signs of a partial heat seal, which may indicate inadequate sterility.
The recall states that a small percentage of packages have inadequate seals, so it is not safe to use without checking the seal first.
Look for model number NM-400U-0423 on the packaging, or check if it was sold in the listed series: 01K through 0XK, 98K through 9ZK, and 05V through 09V.
Inspect the packaging for a partial heat seal. If the seal is inadequate, contact Olympus 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-1017-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1017-2021 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.