Olympus recalls NEEDLEMASTER 6MMx 21G UPPER (model NM-610L-0621) due to potential packaging failures that could lead to infections. Affected units were sold with specific model 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 endoscopic needle model because some sterile packages have weak seals that could let bacteria in. Using these needles might cause infections during medical procedures.
The sterile packaging may not seal properly, allowing bacteria to enter the needle. If the needle is used without proper sterility, it could cause infections during medical procedures.
Healthcare professionals using this needle during endoscopic procedures. Patients at risk if the needle becomes contaminated due to poor packaging.
Check for model number NM-610L-0621 on the packaging. This needle was sold with specific model codes: 02K, 09K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Look for model number NM-610L-0621 on the packaging or label.
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.
Check for model number NM-610L-0621 on the packaging. This needle was sold with specific model codes: 02K, 09K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1037-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1037-2021 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.
