Olympus recalls INJECTOR FORCEMAX LOWER 23G 5MM (model NM-400U-0523) due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used.
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 device's sterile packaging may have partial heat seals, meaning the packaging isn't fully sealed. If the packaging isn't sealed properly, the device could become non-sterile, leading to infections during medical procedures.
Healthcare professionals using this device for endoscopic procedures may be affected. Patients receiving treatment with this device are at risk if the seal is inadequate.
Look for the model number NM-400U-0523 on the device. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the packaging for signs of partial heat sealing, which may indicate inadequate sterility.
The recall indicates a small percentage of packages have inadequate seals, so it's not guaranteed safe. Users should check for seal issues before use.
Look for the model number NM-400U-0523 on the device, and check the batch codes (01K through 9ZK and 05V through 09V).
The recall does not specify a remedy, so users should check the packaging seal and contact Olympus if concerns arise.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1019-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1019-2021 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.
