Olympus recalls NEEDLEMASTER 5MMx21G Upper (model NM-610L-0521) due to potential inadequate sterile packaging seals. Patients could develop infections if non-sterile equipment is used. Affected units sold in specific regions and model numbers.
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 its NEEDLEMASTER 5MMx21G Upper (model NM-610L-0521) because some sterile packages have inadequate seals. This could lead to infections if non-sterile equipment is used during medical procedures. The recall affects specific model numbers sold in certain regions.
The sterile packaging may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients might develop infections.
Healthcare professionals using the NEEDLEMASTER 5MMx21G Upper for endoscopic procedures in the GI tract. Patients at risk if non-sterile equipment is used during procedures.
Check for model number NM-610L-0521 on the product. The product was sold in specific regions and with certain lot codes (01K, 05K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV).
Inspect the packaging for partial heat seals that may indicate inadequate sterility.
The recall is due to a small percentage of sterile packages having inadequate package seals, which could lead to infections if non-sterile equipment is used during procedures.
Check for model number NM-610L-0521 and lot codes 01K, 05K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, or 0XV.
The official recall notice 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-1034-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1034-2021 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.
