Olympus recalls certain INJECTOR FORCEMAX LOWER 23G 3MM endoscopic needles due to potential inadequate package seals that 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 inadequate seals, which could lead to infections if non-sterile equipment is used. This affects medical devices used during endoscopic procedures for treating digestive tract conditions.
The recalled needles have a small percentage of sterile packages with partial heat seals. This could allow contaminants to enter the package, potentially causing infections if the equipment is not properly sterile during medical procedures.
Healthcare professionals using the recalled needles for endoscopic procedures are most at risk. Patients using these needles for esophageal and gastric varices treatment may face infection risks if non-sterile equipment is used.
Check for the model number NM-400U-0323 on the product. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V, 0XV.
Inspect the package for adequate heat sealing; if the seal appears damaged or incomplete, do not use the product.
Inspection confirmed a small percentage of sterile packages have inadequate heat seals, which could lead to infections if non-sterile equipment is used during medical procedures.
The model number is NM-400U-0323.
Look for the model number NM-400U-0323 on the product, which was sold in specific batches labeled 01K through 9ZK and 05V through 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-1001-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1001-2021 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.
