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-401L-0625 with certain batch 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 device is used without proper sterility.
The sterile packaging has a partial heat seal, meaning the device might not be sterile. If non-sterile equipment is used during procedures, patients could develop infections.
Healthcare professionals using the injector for endoscopic procedures may be affected. Patients at risk are those receiving treatments with the recalled device.
Check for model number NM-401L-0625 with batch codes 01K, 02K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Look for the model number NM-401L-0625 on the product packaging.
The sterile packaging has a partial heat seal, which could lead to infections if non-sterile equipment is used during procedures.
The recall record does not specify a remedy, so contact Olympus directly for guidance.
Batch codes 01K, 02K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV are affected.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1029-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1029-2021 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.
