Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 23G 6MM endoscopic injection devices due to potential inadequate package seals that 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 a specific endoscopic injection device model because some packages have inadequate seals, which could lead to infections if the device is not sterile. This affects medical users who perform endoscopic procedures.
The device comes in sterile packages that sometimes have partial heat seals. If the seal is inadequate, the device may not be sterile, increasing the risk of infection for patients during medical procedures.
Medical professionals using this device for endoscopic procedures are most at risk. Patients using the device for esophageal and gastric varices treatment may be affected if the device is not sterile.
Check for the model number NM-401L-0623 on the device. The product was sold in specific batches labeled 02K, 03K, 04K, 06K, 05V, 06V, 07V, 08V, 09V, or 0XV.
Inspect the package for signs of inadequate sealing, such as gaps or improper heat sealing.
The device may have inadequate package seals in some units, which could lead to infections if not sterile. Always check the seal before use.
Look for the model number NM-401L-0623 and batch labels 02K, 03K, 04K, 06K, 05V, 06V, 07V, 08V, 09V, or 0XV on the device packaging.
Inspect the package seal for adequacy. If the seal appears compromised, contact Olympus for guidance on next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1028-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1028-2021 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.
