Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, which may lead to infections if used improperly. Affected models include NM-400L-0523 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 device is used without proper sterility.
The sterile packaging may not seal properly, allowing contaminants to enter the device. If non-sterile equipment is used during procedures, patients could develop infections.
Healthcare professionals using endoscopes for digestive tract procedures may be affected. Patients receiving injections with this device are at risk if the seal is compromised.
Check for the model number NM-400L-0523 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 signs of inadequate sealing, such as leaks or improper adhesion.
The recall indicates a small percentage of packages have inadequate seals, so it may not be safe. Always check the seal before use.
The recall does not specify a remedy, so contact Olympus directly for guidance.
Look for the model number NM-400L-0523 with serial numbers starting with 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0996-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0996-2021 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.
