Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM endoscopic injection devices due to inadequate sterile packaging seals, which may cause 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 devices because some sterile packages have poor seals. This could lead to infections if the devices are used without proper sterility.
The sterile packaging has partial heat seals, meaning the devices might not be sterile. If non-sterile equipment is used during procedures, patients could develop infections.
Healthcare professionals using endoscopes for digestive tract procedures may be affected. Patients receiving injections with these devices are at risk of infection.
Check for model number NM-400L-0625 on the device. These were sold in the U.S. from 2001 through 2009 with specific batch codes like 01K, 04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the packaging for partial heat seals that may indicate inadequate sterility.
The recall states that a small percentage of packages have inadequate seals, so they may not be sterile. Use only devices with confirmed proper seals.
Look for model number NM-400L-0625 with batch codes 01K, 04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
The recall does not specify a remedy, so check the packaging seal and contact Olympus if you have concerns.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1000-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1000-2021 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.
