Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM models 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 specific endoscopic injectors because some sterile packages have poor seals. This could lead to infections if the equipment is used without proper sterility.
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.
Patients using endoscopic procedures with these injectors may be at risk of infection if the equipment is not sterile. Healthcare providers who use these devices for treating esophageal and gastric varices are most affected.
Check for model number NM-400L-0421 on the packaging. These injectors were sold with specific lot codes: 03K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV.
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 during procedures.
Model NM-400L-0421 with lot codes 03K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check for model number NM-400L-0421 and lot codes listed above on the packaging.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1009-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1009-2021 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.
