Olympus recalls specific ultrasound needle models for slight resistance during use. Affected units may cause minor discomfort but not serious injury. Return or stop using immediately.
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Olympus recalls certain ultrasound needles used for fine needle aspiration (FNA) due to slight resistance during needle advancement. This could cause minor discomfort but not serious injury.
The needles do not meet manufacturing specifications for angle, causing slight resistance when advancing or retracting. This may lead to minor discomfort but not serious injury.
Users of ultrasound-guided fine needle aspiration (FNA) procedures with the recalled needles. Healthcare professionals performing FNA on submucosal and extramural lesions are most at risk.
Check for model numbers NA-U401SX-4022 or NA-U401SX-4022-A. Lot numbers include KR248740 through KR260937. These needles are sold with ultrasound endoscopes for FNA procedures.
Discontinue use of the recalled needles as they may cause slight resistance during needle advancement.
The needles do not meet manufacturing specifications for angle, causing slight resistance during needle advancement and retraction.
Check for model numbers NA-U401SX-4022 or NA-U401SX-4022-A and lot numbers from KR248740 to KR260937.
The recall record does not specify a return process, but you should stop using them immediately.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1616-2023 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.
