Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM models due to inadequate sterile packaging seals that could lead to infections. Affected units were sold in specific 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 some endoscopic injectors because their sterile packaging may have poor seals. This could let bacteria enter the equipment, causing infections during medical procedures.
The sterile packaging may not seal properly, allowing bacteria to enter the equipment. If non-sterile equipment is used during procedures, patients could develop infections.
Patients using these injectors for endoscopic procedures are at risk of infection if the packaging seal is compromised. Medical professionals who use the device for treating esophageal and gastric varices are most affected.
Check for model number NM-400L-0525 on the packaging. These units were sold in specific batches: 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the packaging for signs of a poor seal, such as bulging or leaks.
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-0525 was sold in specific batches: 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check for model number NM-400L-0525 on the packaging and verify the batch code matches the listed batches.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1014-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1014-2021 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.
