Olympus recalls INJECTOR FORCEMAX 25G 2.5MM (model NM-400U-0425) due to potential inadequate sterile packaging seals. Patients could develop infections if non-sterile equipment is used. Affected units were 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 type of 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 the device. If the device is not sterile, it could cause infections during medical procedures.
Healthcare professionals using this device for endoscopic procedures may be affected. Patients receiving treatment with this device could be at risk of infection.
Check for the model number NM-400U-0425 on the device. Affected units were sold in specific batches labeled 01K through 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V through 09V, 0XV.
Inspect the packaging for signs of a poor seal, though the recall does not specify visual indicators.
The recall states that the hazard is a potential inadequate seal in the packaging, not a problem with the device itself when used correctly.
Look for the model number NM-400U-0425 and check the batch labels listed in the recall notice.
The recall does not specify a stop-use instruction, so users can continue using it if they check the packaging seal.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1018-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1018-2021 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.
