Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 25G 5MM endoscopic injectors due to inadequate sterile packaging seals that could lead to infections. Affected models include NM-401L-0525 with serial numbers 01K-09ZK.
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 that could cause infections if used. This affects medical devices used for treating digestive tract conditions.
The sterile packaging may have partial heat seals, meaning the device could become non-sterile. If non-sterile equipment is used during procedures, patients might develop infections.
Healthcare professionals using the INJECTOR FORCEMAX UP 2MM CH 25G 5MM model for endoscopic procedures are most at risk. Patients receiving treatments with this device could face infections if the seal is compromised.
Check for the model number NM-401L-0525 with serial numbers starting with 01K through 09ZK (e.g., 05V, 06V, 07V, 08V, 09V, 0XV). This device is used for endoscopic injections in digestive tract treatments.
Inspect the sterile packaging for partial heat seals that may compromise sterility.
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.
The model number NM-401L-0525 with serial numbers 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Look for the model number NM-401L-0525 with serial numbers starting with 01K through 09ZK (e.g., 05V, 06V, 07V, 08V, 09V, 0XV).
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1027-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1027-2021 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.