Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, which may lead to infections if used improperly. Affected models include NM-400L-0425 with certain 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 may have partial heat seals, allowing contaminants to enter. If the injector is not properly sterile, it could cause infections during medical procedures.
Healthcare professionals using endoscopes for digestive tract procedures may be affected. Patients receiving treatments with this injector could face infection risks if the seal is compromised.
Check for model number NM-400L-0425 with serial numbers starting with 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
Inspect the sterile packaging for partial heat seals that may allow contamination.
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.
Model NM-400L-0425 with serial numbers starting with 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
Look for the model number NM-400L-0425 and serial numbers matching the list provided 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-0995-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0995-2021 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.
