Olympus recalls certain INJECTOR FORCEMAX LOWER 25G 6MM endoscopic injection devices due to inadequate sterile packaging seals, which may 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 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 may have partial heat seals, meaning the devices could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients may develop infections.
Healthcare professionals using the recalled model numbers for endoscopic procedures are affected. Patients receiving treatments with these devices face the risk of infection.
Check for model numbers NM-400U-0625 with the following series: 01K, 02K, 03K, 05K, 06K, 09K, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV. These devices are used for endoscopic injections in the digestive tract.
Verify the model number on the device to see if it matches the recalled series.
Reach out to Olympus for guidance on next steps if the device is recalled.
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.
The affected model numbers are NM-400U-0625 with series: 01K, 02K, 03K, 05K, 06K, 09K, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check the model number on the device against the listed series to determine if it is recalled.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1022-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1022-2021 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.
