Olympus recalls NEEDLEMASTER 3MMx 23G Lower (model NM-610U-0523) due to inadequate sterile package seals that could cause infections if non-sterile equipment is used. Affected units were sold in specific batches.
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 endoscopic needle used in medical procedures because some sterile packages have poor seals. This could lead to infections if the equipment is not properly sterile. Patients using these needles should contact Olympus for details.
The sterile packages may have partial heat seals, meaning they aren't properly sealed. If the package isn't sealed correctly, the needle could become contaminated, leading to infections during medical procedures.
Healthcare professionals using the NEEDLEMASTER 3MMx 23G Lower needle during endoscopic procedures. Patients receiving these procedures are at risk if the equipment is not sterile.
Check for the model number NM-610U-0523 on the package. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the sterile package for proper sealing; if the seal appears damaged or incomplete, do not use the needle.
The recall states that a small percentage of packages have inadequate seals, so it's not safe to use without checking the seal first.
The recall does not specify a remedy, so contact Olympus directly for guidance on whether to use or discard the product.
The affected batches are labeled 01K, 02K, 03K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 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-1045-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1045-2021 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.
