Olympus recalls certain INJECTOR FORCEMAX LOWER 25G 5MM endoscopic needles due to inadequate sterile packaging seals that could lead to infections. Affected models include NM-400U-0525 with specific batch codes.
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 endoscopic injection needles because some sterile packages have poor seals that could cause infections if used. This is a safety issue for medical procedures involving these needles.
The sterile packaging may have partial heat seals, meaning the needles could become non-sterile. If non-sterile needles are used during medical procedures, patients might develop infections.
Healthcare professionals using the recalled needles for endoscopic procedures are most at risk. Patients using these needles for esophageal and gastric varices treatment could be affected.
Check for model number NM-400U-0525 with batch codes 01K through 9ZK and 05V through 09V.
Inspect the sterile packaging for partial heat seals that may compromise sterility.
The recall is due to a small percentage of sterile packages having inadequate seals, which could lead to infections if non-sterile equipment is used.
The affected models are NM-400U-0525 with batch codes 01K, 02K through 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, and 0XV.
Look for model number NM-400U-0525 with specific batch codes 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-1005-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1005-2021 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.
