Olympus recalls specific endoscopic injectors due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected models include NM-400L-0621 with serial numbers 01K through 0XV.
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 certain endoscopic injectors that may have inadequate sterile packaging seals. Using these injectors could lead to infections if the equipment is not properly sterile.
The sterile packaging may have a partial heat seal, meaning the equipment could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients might develop infections.
Healthcare professionals using the recalled injectors for endoscopic procedures are most at risk. Patients receiving treatments with these devices could face infection if the equipment is not sterile.
Check for the model number NM-400L-0621 with serial numbers starting with 01K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
Inspect the packaging for signs of a partial heat seal, which may indicate inadequate sterility.
The recall is due to a small percentage of sterile packages having inadequate package seals, which could lead to infections if non-sterile equipment is used.
The affected models are NM-400L-0621 with serial numbers starting with 01K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
Check the model number on the packaging and look for the serial numbers listed above.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1010-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1010-2021 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.
