Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 25G 4MM models due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units include specific model numbers and production 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 certain INJECTOR FORCEMAX UP 2MM CH 25G 4MM endoscopic injection devices because some sterile packages have inadequate seals. This could lead to infections if non-sterile equipment is used during medical procedures.
The sterile packaging may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients might develop infections.
Healthcare professionals using the device for endoscopic procedures are most at risk. Patients receiving treatment with the recalled device may face infection risks if the equipment is not sterile.
Check for model number NM-401L-0425 and production batches 01K through 09ZK, 05V through 09V, 0XV, 0YV, 0ZV.
Inspect the packaging for partial heat seals that may indicate inadequate sterility.
The recall is due to a small percentage of sterile packages having inadequate package seals, which could lead to infections if non-sterile equipment is used.
Model number NM-401L-0425 with production batches 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check for model number NM-401L-0425 and production batches listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1025-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1025-2021 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.
