Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected models include NM-400L-0623 with certain endoscope codes.
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 some packages may not be properly sealed. If the injector is used without being sterile, patients could develop infections.
Healthcare professionals using endoscopes for digestive procedures may be affected. Patients receiving treatments with this injector are at risk if the seal is compromised.
Check for model number NM-400L-0623 with endoscope codes 01K, 02K, 03K, 05K, 07K, 08K, 09K, 99K, 9XK, 9YK, or 9ZK. The product is used for endoscopic injections in the digestive tract.
Inspect the sterile packaging for a partial heat seal that may allow contamination.
The recall indicates a small percentage of packages have inadequate seals, so it may not be sterile. Do not use if the seal appears compromised.
Look for model number NM-400L-0623 with endoscope codes 01K, 02K, 03K, 05K, 07K, 08K, 09K, 99K, 9XK, 9YK, or 9ZK.
Inspect the packaging for a partial heat seal. If the seal is compromised, do not use the product and contact Olympus for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0999-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0999-2021 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.