Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM models due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. 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 certain INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM endoscopic injection devices because some sterile packages have inadequate seals. This could lead to infections if non-sterile equipment is used during medical procedures.
The sterile packages may have partial heat seals, meaning they are not properly sealed. If the package is not sealed correctly, the equipment could become non-sterile, increasing the risk of infection during medical procedures.
Medical professionals using these devices for endoscopic procedures may be affected. Patients undergoing treatment with the recalled devices are at risk of infection if non-sterile equipment is used.
Check for the model number NM-400L-0423 on the device. Affected units were sold in specific batches: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the sterile package for proper sealing; if the seal appears damaged or incomplete, do not use the device.
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 medical procedures.
The affected model number is NM-400L-0423, sold in specific batches: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check for the model number NM-400L-0423 on the device and verify the batch code (01K through 0XV).
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0994-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0994-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
