Olympus recalls certain endoscopic injectors due to inadequate sterile packaging seals, which may lead to infections if non-sterile equipment is used. Affected models include NM-400Y-0423 with specific serial numbers.
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 injector model because some sterile packages have poor seals. This could lead to infections if the injector is used without proper sterility.
The sterile packaging has a partial heat seal, meaning it might not stay sealed properly. If the package isn't sealed well, the injector could become contaminated, increasing the risk of infection during medical procedures.
Healthcare professionals using the injector for endoscopic procedures are most at risk. Patients receiving treatments with this device may be affected if the injector is not sterile.
Check for the model number NM-400Y-0423 on the product. The serial numbers include 03K, 04K, 05K, 07K, 0XK, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the packaging for a partial heat seal that may allow contamination.
The sterile packaging has a partial heat seal, which could lead to contamination and infection if the injector is used without proper sterility.
The affected model is NM-400Y-0423 with serial numbers including 03K, 04K, 05K, 07K, 0XK, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV.
Look for the model number NM-400Y-0423 and the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1023-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1023-2021 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.
