Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM models due to inadequate sterile packaging seals, which may lead to infections if non-sterile equipment is used. Affected units include specific model numbers and 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 type of medical injector used with endoscopes because some packages have poor seals that could let infections enter the body. This is serious for patients who might use the device without knowing the packaging is compromised.
The sterile packaging on some units has a partial heat seal, meaning the seal might not hold properly. If the packaging isn't sealed well, the device could become non-sterile, increasing the risk of infection during medical procedures.
Patients using endoscopes for digestive tract procedures may be affected. Those who have received the specific model numbers listed in the recall are most at risk.
Check for model number NM-400L-0623 on the packaging. Affected units were sold with batch codes including 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the packaging for a partial heat seal 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 number NM-400L-0623 with batch codes including 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Check the model number on the packaging; affected units have model number NM-400L-0623 and specific batch codes listed in the recall.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1012-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1012-2021 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.
