Olympus recalls certain INJECTOR FORCEMAX Lower 23G 3MM endoscopic needles due to inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used.
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 specific endoscopic injection needles because some packages have poor seals that might allow contamination. Using these needles could lead to infections in patients.
The sterile packaging on some needles has a partial heat seal, meaning the seal might not be tight enough. If the packaging isn't sealed properly, the needles could become contaminated, increasing the risk of infection for patients during procedures.
Patients undergoing endoscopic procedures using the recalled needles are at risk. Healthcare providers using these needles for treating esophageal and gastric varices or digestive tract injections may be affected.
Check for the model number NM-400U-0323 on the packaging. The product was sold with endoscope use for treating esophageal and gastric varices or digestive tract injections.
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.
The model number is NM-400U-0323.
Check the packaging for the model number NM-400U-0323, which was sold with endoscope use for treating esophageal and gastric varices or digestive tract injections.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1016-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1016-2021 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.
